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Dr.bruno Lange Mini-HBA1 Photometer

by Diversa Corp. 510(k)

Active United States

510(k) K865055

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK865055 Date19 Mar 1987ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GKR
Device Class
Class II
Regulation
21 CFR Part 864.5620
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 Dr. Bruno Lange Mini-HBA1 Photometer is a system for hemoglobin analysis, classified as an automated hemoglobin system under the hematology medical specialty. It is a flame emission photometer designed for clinical use in measuring hemoglobin levels.

This device received FDA 510(k) clearance (K865055) on March 19, 1987, as substantially equivalent to a predicate device. It is classified as a Class II medical device under regulation number 864.5620 and product code GKR, and is intended for use in clinical laboratory settings.

Questions

AI-generated answers, 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.

  • What clinical specialty is the Dr. Bruno Lange Mini-HBA1 Photometer designed for, and how does it function?

    The Dr. Bruno Lange Mini-HBA1 Photometer is designed for use in clinical laboratory settings within the hematology specialty. It functions as a flame emission photometer, specifically measuring hemoglobin levels in patient samples. This automated system streamlines hemoglobin analysis, which is critical for diagnosing and monitoring conditions like anemia, polycythemia, and other blood-related disorders.

  • Is this device intended for single-use or repeated use in a clinical setting, and how is it supplied?

    The device data does not explicitly state whether the Dr. Bruno Lange Mini-HBA1 Photometer is single-use or reusable. However, as a flame emission photometer used in clinical laboratories, it is likely designed for repeated use with proper maintenance and calibration. It is supplied as a complete system for hemoglobin analysis, though specific packaging details (e.g., accessories, reagents, or consumables) are not provided in the data.

  • What regulatory pathway was followed for FDA clearance, and what classification does this device hold?

    The Dr. Bruno Lange Mini-HBA1 Photometer received FDA 510(k) clearance under the Traditional 510(k) review pathway, with a decision date of March 19, 1987. It was classified as substantially equivalent (SESE) to a predicate device and is categorized as a Class II medical device under regulation number 864.5620, with the product code GKR. This classification indicates it is subject to special controls for automated hemoglobin systems in hematology.

  • Are there multiple models or sizes available for this photometer, and how would one identify them?

    The data lists multiple FEI (Facility Equipment Identifier) numbers associated with the Dr. Bruno Lange Mini-HBA1 Photometer, suggesting there may be variations or different units registered under this name. However, the exact differences in models or sizes (e.g., technical specifications, software versions, or physical configurations) are not detailed in the provided information. To confirm specific models, one would need to consult the manufacturer’s documentation or contact Diversa Corp. directly.