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FDA 510(k)

CLINISTAT GLUCOSE REAGENT TEST

K-Number: K884756 · 1989-01-13

ApplicantHeraeus Kulzer, Inc.
Decision Date1989-01-13
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINISTAT GLUCOSE 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 1989-01-13 under 510(k) number K884756. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINISTAT GLUCOSE REAGENT TEST?

CLINISTAT GLUCOSE REAGENT TEST is a medical device that received FDA 510(k) clearance on 1989-01-13. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K884756.

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

CLINISTAT GLUCOSE REAGENT TEST received FDA 510(k) clearance on 1989-01-13, under 510(k) number K884756.

Who is the listed applicant for CLINISTAT GLUCOSE 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 GLUCOSE REAGENT TEST?

The FDA product code for CLINISTAT GLUCOSE REAGENT TEST is CGA.

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Other records listing Heraeus Kulzer, Inc. as applicant

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Related Devices (Code: CGA)

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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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