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FDA 510(k)

CLINISTAT HEMOGLOBIN REAGENT TEST

K-Number: K885227 · 1989-02-24

ApplicantHeraeus Kulzer, Inc.
Decision Date1989-02-24
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLINISTAT HEMOGLOBIN REAGENT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1989-02-24 under 510(k) number K885227. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINISTAT HEMOGLOBIN REAGENT TEST?

CLINISTAT HEMOGLOBIN REAGENT TEST is a medical device that received FDA 510(k) clearance on 1989-02-24. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K885227.

When did CLINISTAT HEMOGLOBIN REAGENT TEST receive FDA 510(k) clearance?

CLINISTAT HEMOGLOBIN REAGENT TEST received FDA 510(k) clearance on 1989-02-24, under 510(k) number K885227.

Who is the listed applicant for CLINISTAT HEMOGLOBIN REAGENT TEST?

The FDA 510(k) record lists Heraeus Kulzer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLINISTAT HEMOGLOBIN REAGENT TEST?

The FDA product code for CLINISTAT HEMOGLOBIN REAGENT TEST is KHG.

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Related Devices (Code: KHG)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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