ELVI ACID & PROSTATIC PHOSPHATASE

Acid Phosphatase (prostatic), Tartrate Inhibited

VOLU SOL MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Elvi Acid & Prostatic Phosphatase.

Pre-market Notification Details

Device IDK792405
510k NumberK792405
Device Name:ELVI ACID & PROSTATIC PHOSPHATASE
ClassificationAcid Phosphatase (prostatic), Tartrate Inhibited
Applicant VOLU SOL MEDICAL INDUSTRIES 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 Received1979-11-26
Decision Date1979-12-07

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