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FDA 510(k)

LACTATE DEHYDROGENASE QVET

K-Number: K942964 · 1994-12-29

ApplicantPrisma Systems
Decision Date1994-12-29
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTATE DEHYDROGENASE QVET is the device name listed in this FDA 510(k) record. The listed applicant is Prisma Systems. It received FDA 510(k) clearance on 1994-12-29 under 510(k) number K942964. 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 LACTATE DEHYDROGENASE QVET?

LACTATE DEHYDROGENASE QVET is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Prisma Systems. The 510(k) number is K942964.

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

LACTATE DEHYDROGENASE QVET received FDA 510(k) clearance on 1994-12-29, under 510(k) number K942964.

Who is the listed applicant for LACTATE DEHYDROGENASE QVET?

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

What is the FDA product code for LACTATE DEHYDROGENASE QVET?

The FDA product code for LACTATE DEHYDROGENASE QVET is CFJ.

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Other records listing Prisma Systems 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.

K950177CK QVETK943027CHOLESTEROL QVETK943042BUN QVETK942963GLUCOSE QVETK942997ALKALINE PHOSPHATASE (ALKP) QVETK943001MAGNESIUM QVET

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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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