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FDA 510(k)

AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE

K-Number: K951877 · 1996-05-14

ApplicantChimera Research & Chemical, Inc.
Decision Date1996-05-14
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE is the device name listed in this FDA 510(k) record. The listed applicant is Chimera Research & Chemical, Inc.. It received FDA 510(k) clearance on 1996-05-14 under 510(k) number K951877. 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 AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE?

AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE is a medical device that received FDA 510(k) clearance on 1996-05-14. The listed applicant is Chimera Research & Chemical, Inc.. The 510(k) number is K951877.

When did AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE receive FDA 510(k) clearance?

AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE received FDA 510(k) clearance on 1996-05-14, under 510(k) number K951877.

Who is the listed applicant for AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE?

The FDA 510(k) record lists Chimera Research & Chemical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE?

The FDA product code for AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE is KQO.

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Other records listing Chimera Research & Chemical, Inc. 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.

K970087CR PERFECTK953393TOX PERFECT A TUBEK952501TOX PERFECT B TUBES AND REAGENTSK950142CR PERFECTK940768AD PERFECTK935408UA PERFECT

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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.

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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