RIA KIT, QUANTITATION OF PROSTATIC ACID

Acid Phosphatase (prostatic), Tartrate Inhibited

NEW ENGLAND NUCLEAR

The following data is part of a premarket notification filed by New England Nuclear with the FDA for Ria Kit, Quantitation Of Prostatic Acid.

Pre-market Notification Details

Device IDK790817
510k NumberK790817
Device Name:RIA KIT, QUANTITATION OF PROSTATIC ACID
ClassificationAcid Phosphatase (prostatic), Tartrate Inhibited
Applicant NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJFH  
CFR Regulation Number862.1020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-27
Decision Date1979-05-07

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