GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT

Radioimmunoassay, Testosterones And Dihydrotestosterone

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Gamma Coat Assay Testosterone Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK915570
510k NumberK915570
Device Name:GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactEllen Best
CorrespondentEllen Best
INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-12
Decision Date1992-01-27

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