FDA 510(k)

SINGLE VIAL LDH-L TRIS

K-Number: K781538 · 1978-10-03

Decision Date1978-10-03

Product CodeCFJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SINGLE VIAL LDH-L TRIS is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1978-10-03 under 510(k) number K781538. 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 SINGLE VIAL LDH-L TRIS?

SINGLE VIAL LDH-L TRIS is a medical device that received FDA 510(k) clearance on 1978-10-03. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K781538.

When did SINGLE VIAL LDH-L TRIS receive FDA 510(k) clearance?

SINGLE VIAL LDH-L TRIS received FDA 510(k) clearance on 1978-10-03, under 510(k) number K781538.

Who is the listed applicant for SINGLE VIAL LDH-L TRIS?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE VIAL LDH-L TRIS?

The FDA product code for SINGLE VIAL LDH-L TRIS is CFJ.

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Related Devices (Code: CFJ)

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.