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Seralyzer Hemoglobin Calibrators

by Miles Laboratories, Inc. 510(k)

Active United States

510(k) K822046

Overview

The Seralyzer Hemoglobin Calibrators are Calibrators for Hemoglobin and Hematocrit Measurement, designed to ensure accurate calibration of hematology analyzers. These calibrators provide standardized reference values for hemoglobin and hematocrit assays, supporting reliable diagnostic testing in clinical hematology.

Supplied as single-use liquid calibrators, these devices are intended for use in laboratory settings with hematology analyzers. They are regulated under FDA 510(k) clearance (K822046) and fall under the Hematology advisory committee classification, adhering to Class II device standards. Storage and handling instructions are manufacturer-specific, though no MRI safety or reusable design is indicated in the regulatory data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822046 Date30 Jul 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KRZ
Device Class
Class II
Regulation
21 CFR Part 864.8165
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the Seralyzer Hemoglobin Calibrators in a clinical lab setting?

    The Seralyzer Hemoglobin Calibrators are designed to provide standardized reference values for hemoglobin and hematocrit assays. Their purpose is to ensure the accuracy and reliability of hematology analyzers, which is critical for diagnosing and monitoring blood-related conditions in clinical settings.

  • Are the Seralyzer Hemoglobin Calibrators intended for single-use or repeated use?

    The Seralyzer Hemoglobin Calibrators are explicitly supplied as single-use liquid calibrators. This design minimizes contamination risks and ensures consistent, accurate calibration for each measurement cycle.

  • How are these calibrators regulated, and what does that mean for purchasing or using them?

    These calibrators are regulated under the FDA’s 510(k) clearance process, specifically classified under the Hematology advisory committee (HE) and fall under Class II device standards. This means they have undergone review to demonstrate substantial equivalence to a predicate device, ensuring they meet safety and performance requirements for use in clinical hematology testing.

  • What type of storage or handling instructions should be followed for the Seralyzer Hemoglobin Calibrators?

    While the regulatory data does not specify storage details, the manufacturer provides specific instructions for handling these single-use liquid calibrators. It’s important to follow those guidelines to maintain stability and accuracy, though they are not reusable and should not be exposed to conditions that could compromise their integrity.