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FDA 510(k)

UA PERFECT

K-Number: K935408 · 1994-06-13

ApplicantChimera Research & Chemical, Inc.
Decision Date1994-06-13
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UA PERFECT 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 1994-06-13 under 510(k) number K935408. 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 UA PERFECT?

UA PERFECT is a medical device that received FDA 510(k) clearance on 1994-06-13. The listed applicant is Chimera Research & Chemical, Inc.. The 510(k) number is K935408.

When did UA PERFECT receive FDA 510(k) clearance?

UA PERFECT received FDA 510(k) clearance on 1994-06-13, under 510(k) number K935408.

Who is the listed applicant for UA PERFECT?

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 UA PERFECT?

The FDA product code for UA PERFECT 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 PERFECTK951877AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINEK953393TOX PERFECT A TUBEK952501TOX PERFECT B TUBES AND REAGENTSK950142CR PERFECTK940768AD 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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