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FDA 510(k)

CREATINE KINASE UV REAGENT SET

K-Number: K905588 · 1991-01-17

ApplicantBiochemical Trade, Inc.
Decision Date1991-01-17
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE UV REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Trade, Inc.. It received FDA 510(k) clearance on 1991-01-17 under 510(k) number K905588. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATINE KINASE UV REAGENT SET?

CREATINE KINASE UV REAGENT SET is a medical device that received FDA 510(k) clearance on 1991-01-17. The listed applicant is Biochemical Trade, Inc.. The 510(k) number is K905588.

When did CREATINE KINASE UV REAGENT SET receive FDA 510(k) clearance?

CREATINE KINASE UV REAGENT SET received FDA 510(k) clearance on 1991-01-17, under 510(k) number K905588.

Who is the listed applicant for CREATINE KINASE UV REAGENT SET?

The FDA 510(k) record lists Biochemical Trade, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATINE KINASE UV REAGENT SET?

The FDA product code for CREATINE KINASE UV REAGENT SET is JHW.

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Other records listing Biochemical Trade, 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.

K942958CREATINE KINASE MB DETERMINATION (UV)K910635TOTAL BILIRUBIN REAGENT SETK910296PHOSPHORUS (INORGANIC) TEST SYSTEMK905776ALBUMIN REAGENT SETK905790TOTAL PROTEIN REAGENT SETK905650KINETIC ALKALINE PHOSPHATASE DETERMINATION

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Related Devices (Code: JHW)

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.

K162526Creatine Kinase-MBRoche DiagnosticsK122083ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroupK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354Wiener Laboratories SaicK003158ROCHE DIAGNOSTICS CK-MBRoche Diagnostics Corp.K961501ELECSYS CK-MBBoehringer Mannheim Corp.K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMiles, 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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