DIRECT TESTOSTERONE RIA

Radioimmunoassay, Testosterones And Dihydrotestosterone

IMMUCHEM CORP.

The following data is part of a premarket notification filed by Immuchem Corp. with the FDA for Direct Testosterone Ria.

Pre-market Notification Details

Device IDK811536
510k NumberK811536
Device Name:DIRECT TESTOSTERONE RIA
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant IMMUCHEM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-01
Decision Date1981-06-18

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