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FDA 510(k)

BAYER CLINITEK STATUS ANALYZER

K-Number: K031947 · 2003-12-19

ApplicantBayer Healthcare, LLC
Decision Date2003-12-19
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BAYER CLINITEK STATUS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K031947. The device is classified under product code KQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER CLINITEK STATUS ANALYZER?

BAYER CLINITEK STATUS ANALYZER is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K031947.

When did BAYER CLINITEK STATUS ANALYZER receive FDA 510(k) clearance?

BAYER CLINITEK STATUS ANALYZER received FDA 510(k) clearance on 2003-12-19, under 510(k) number K031947.

Who is the listed applicant for BAYER CLINITEK STATUS ANALYZER?

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

What is the FDA product code for BAYER CLINITEK STATUS ANALYZER?

The FDA product code for BAYER CLINITEK STATUS ANALYZER is KQO.

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Other records listing Bayer Healthcare, LLC as applicant

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K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)K121190CONTOUR NEXT BLOOD GLUCOSE METERK110587CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)K093930DIDGET WORLD REPORTSK090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

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Related Devices (Code: KQO)

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.

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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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