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FDA 510(k)

CLINITEK MICROALBUMIN REAGENT STRIPS

K-Number: K972706 · 1997-09-09

ApplicantBayer Corp.
Decision Date1997-09-09
Product CodeCJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINITEK MICROALBUMIN REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1997-09-09 under 510(k) number K972706. The device is classified under product code CJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINITEK MICROALBUMIN REAGENT STRIPS?

CLINITEK MICROALBUMIN REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1997-09-09. The listed applicant is Bayer Corp.. The 510(k) number is K972706.

When did CLINITEK MICROALBUMIN REAGENT STRIPS receive FDA 510(k) clearance?

CLINITEK MICROALBUMIN REAGENT STRIPS received FDA 510(k) clearance on 1997-09-09, under 510(k) number K972706.

Who is the listed applicant for CLINITEK MICROALBUMIN REAGENT STRIPS?

The FDA 510(k) record lists Bayer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLINITEK MICROALBUMIN REAGENT STRIPS?

The FDA product code for CLINITEK MICROALBUMIN REAGENT STRIPS is CJG.

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Other records listing Bayer Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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Official Source

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

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