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FDA 510(k)

CLINITEK 50 URINE CHEMISTRY ANALYZER

K-Number: K960546 · 1996-06-12

ApplicantBayer Corp.
Decision Date1996-06-12
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINITEK 50 URINE CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1996-06-12 under 510(k) number K960546. 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 CLINITEK 50 URINE CHEMISTRY ANALYZER?

CLINITEK 50 URINE CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1996-06-12. The listed applicant is Bayer Corp.. The 510(k) number is K960546.

When did CLINITEK 50 URINE CHEMISTRY ANALYZER receive FDA 510(k) clearance?

CLINITEK 50 URINE CHEMISTRY ANALYZER received FDA 510(k) clearance on 1996-06-12, under 510(k) number K960546.

Who is the listed applicant for CLINITEK 50 URINE CHEMISTRY ANALYZER?

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 50 URINE CHEMISTRY ANALYZER?

The FDA product code for CLINITEK 50 URINE CHEMISTRY ANALYZER is KQO.

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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

View all 96 devices →

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.

K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc.K102188CYBOW READER, MODELS 300 & 720DFI Co., Ltd.K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris IK091472URITEST 50 AND URITEST 500 URINE ANALYZERArj Medical, Inc.K093555COBAS U411 TEST SYSTEMRoche DiagnosticsK093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, Inc.

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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