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FDA 510(k)

ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET

K-Number: K871781 · 1987-06-03

ApplicantBiochemical Trade, Inc.
Decision Date1987-06-03
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAVIOLET LACTATE DEHYDROGENASE 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 1987-06-03 under 510(k) number K871781. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET?

ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1987-06-03. The listed applicant is Biochemical Trade, Inc.. The 510(k) number is K871781.

When did ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET receive FDA 510(k) clearance?

ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET received FDA 510(k) clearance on 1987-06-03, under 510(k) number K871781.

Who is the listed applicant for ULTRAVIOLET LACTATE DEHYDROGENASE 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 ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET?

The FDA product code for ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET is CFJ.

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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: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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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