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FDA 510(k)

CREATINE KINASE MB DETERMINATION (UV)

K-Number: K942958 · 1994-11-21

ApplicantBiochemical Trade, Inc.
Decision Date1994-11-21
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE MB DETERMINATION (UV) 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 1994-11-21 under 510(k) number K942958. 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 MB DETERMINATION (UV)?

CREATINE KINASE MB DETERMINATION (UV) is a medical device that received FDA 510(k) clearance on 1994-11-21. The listed applicant is Biochemical Trade, Inc.. The 510(k) number is K942958.

When did CREATINE KINASE MB DETERMINATION (UV) receive FDA 510(k) clearance?

CREATINE KINASE MB DETERMINATION (UV) received FDA 510(k) clearance on 1994-11-21, under 510(k) number K942958.

Who is the listed applicant for CREATINE KINASE MB DETERMINATION (UV)?

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 MB DETERMINATION (UV)?

The FDA product code for CREATINE KINASE MB DETERMINATION (UV) 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.

K910635TOTAL BILIRUBIN REAGENT SETK910296PHOSPHORUS (INORGANIC) TEST SYSTEMK905776ALBUMIN REAGENT SETK905790TOTAL PROTEIN REAGENT SETK905650KINETIC ALKALINE PHOSPHATASE DETERMINATIONK905619CREATININE (RATE) REAGENT SET

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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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