ELECSYS TESTOSTERONE CALSET II

Calibrator, Secondary

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Testosterone Calset Ii.

Pre-market Notification Details

Device IDK003411
510k NumberK003411
Device Name:ELECSYS TESTOSTERONE CALSET II
ClassificationCalibrator, Secondary
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis,  IN  46250 -0457
ContactKay A Taylor
CorrespondentKay A Taylor
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis,  IN  46250 -0457
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-02
Decision Date2001-03-01

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