PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO

Radioimmunoassay, Testosterones And Dihydrotestosterone

PANTEX, DIV. BIO-ANALYSIS, INC.

The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Pantex Direct Testosterone Coated Tube Radioimmuno.

Pre-market Notification Details

Device IDK853865
510k NumberK853865
Device Name:PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica,  CA  90404
ContactNeil Y Chiamori
CorrespondentNeil Y Chiamori
PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica,  CA  90404
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-09-17
Decision Date1985-10-15

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