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FDA 510(k)

OLYMPUS LACTATE DEHYDROGENASE REAGENT

K-Number: K923412 · 1992-09-18

ApplicantOlympus Corp.
Decision Date1992-09-18
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS LACTATE DEHYDROGENASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1992-09-18 under 510(k) number K923412. 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 OLYMPUS LACTATE DEHYDROGENASE REAGENT?

OLYMPUS LACTATE DEHYDROGENASE REAGENT is a medical device that received FDA 510(k) clearance on 1992-09-18. The listed applicant is Olympus Corp.. The 510(k) number is K923412.

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

OLYMPUS LACTATE DEHYDROGENASE REAGENT received FDA 510(k) clearance on 1992-09-18, under 510(k) number K923412.

Who is the listed applicant for OLYMPUS LACTATE DEHYDROGENASE REAGENT?

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

What is the FDA product code for OLYMPUS LACTATE DEHYDROGENASE REAGENT?

The FDA product code for OLYMPUS LACTATE DEHYDROGENASE REAGENT is CFJ.

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Other records listing Olympus Corp. 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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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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