TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)

Radioimmunoassay, Testosterones And Dihydrotestosterone

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Testosterone Test System; Calibrator; And Quality Control Material (assayed And Unassayed).

Pre-market Notification Details

Device IDK120009
510k NumberK120009
Device Name:TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT 9V6, AP5N-2 Abbott Park,  IL  60064
ContactJohn Rizos
CorrespondentJohn Rizos
ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT 9V6, AP5N-2 Abbott Park,  IL  60064
Product CodeCDZ  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-03
Decision Date2012-09-11
Summary:summary

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