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Calibration Verification Assessment (Cva)

by Streck Laboratories, Inc.

510(k) K960557

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960557 Date3 Apr 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JPK
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Calibration Verification Assessment (CVA) Kit is a mixture classified under hematology quality control, designed to evaluate the linearity and performance of hematology instruments. It serves as an assayed control to assess calibration accuracy and verify patient-reportable ranges for three- and five-part hematology analyzers, ensuring analytical consistency and reliability in laboratory testing.

This kit is supplied as a multi-analyte control in various lot sizes (e.g., 3000, 12x3) and is intended for use in clinical laboratory settings with automated or semi-automated hematology instruments. It is sterile and intended for single-use, with no regulatory indication of MRI compatibility. Authorized under FDA 510(k) clearance (K960557), it adheres to Class II medical device standards (864.8625) and is distributed by Streck Laboratories, Inc.

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