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FDA 510(k)

TEST, LACTATE DEHYDROGENASE

K-Number: K760345 · 1976-10-27

ApplicantPrinceton Biomedix
Decision Date1976-10-27
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TEST, LACTATE DEHYDROGENASE is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Biomedix. It received FDA 510(k) clearance on 1976-10-27 under 510(k) number K760345. 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 TEST, LACTATE DEHYDROGENASE?

TEST, LACTATE DEHYDROGENASE is a medical device that received FDA 510(k) clearance on 1976-10-27. The listed applicant is Princeton Biomedix. The 510(k) number is K760345.

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

TEST, LACTATE DEHYDROGENASE received FDA 510(k) clearance on 1976-10-27, under 510(k) number K760345.

Who is the listed applicant for TEST, LACTATE DEHYDROGENASE?

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

What is the FDA product code for TEST, LACTATE DEHYDROGENASE?

The FDA product code for TEST, LACTATE DEHYDROGENASE is CFJ.

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Other records listing Princeton Biomedix as applicant

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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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