LEECO P.A.P. QUANT. DIAGNOSTIC KIT

Acid Phosphatase (prostatic), Tartrate Inhibited

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco P.a.p. Quant. Diagnostic Kit.

Pre-market Notification Details

Device IDK792652
510k NumberK792652
Device Name:LEECO P.A.P. QUANT. DIAGNOSTIC KIT
ClassificationAcid Phosphatase (prostatic), Tartrate Inhibited
Applicant LEECO DIAGNOSTICS, INC. 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 Received1979-12-21
Decision Date1980-01-16

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