ARCHITECT 2nd Generation Testosterone

Radioimmunoassay, Testosterones And Dihydrotestosterone

Abbott Laboratories

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect 2nd Generation Testosterone.

Pre-market Notification Details

Device IDK152155
510k NumberK152155
Device Name:ARCHITECT 2nd Generation Testosterone
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant Abbott Laboratories 100 Abbott Park Rd, Dept. 093G, Bldg. AP8-1 Abbott Park,  IL  60064
ContactRegina Xavier Kumar
CorrespondentRegina Xavier Kumar
Abbott Laboratories 100 Abbott Park Rd, Dept. 093G, Bldg. AP8-1 Abbott Park,  IL  60064
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-03
Decision Date2015-12-17
Summary:summary

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