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FDA 510(k)

CHEMSTRIP CRITERION URINE ANALYZER

K-Number: K954024 · 1995-10-23

ApplicantBoehringer Mannheim Corp.
Decision Date1995-10-23
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMSTRIP CRITERION URINE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1995-10-23 under 510(k) number K954024. 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 CHEMSTRIP CRITERION URINE ANALYZER?

CHEMSTRIP CRITERION URINE ANALYZER is a medical device that received FDA 510(k) clearance on 1995-10-23. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K954024.

When did CHEMSTRIP CRITERION URINE ANALYZER receive FDA 510(k) clearance?

CHEMSTRIP CRITERION URINE ANALYZER received FDA 510(k) clearance on 1995-10-23, under 510(k) number K954024.

Who is the listed applicant for CHEMSTRIP CRITERION URINE ANALYZER?

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

What is the FDA product code for CHEMSTRIP CRITERION URINE ANALYZER?

The FDA product code for CHEMSTRIP CRITERION URINE ANALYZER is KQO.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: KQO)

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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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