LDH (L-P) REAGENT

Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

GILFORD DIAGNOSTICS

The following data is part of a premarket notification filed by Gilford Diagnostics with the FDA for Ldh (l-p) Reagent.

Pre-market Notification Details

Device IDK800120
510k NumberK800120
Device Name:LDH (L-P) REAGENT
ClassificationNad Reduction/nadh Oxidation, Lactate Dehydrogenase
Applicant GILFORD DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFJ  
CFR Regulation Number862.1440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-01-18
Decision Date1980-02-13

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