ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material

Radioimmunoassay, Testosterones And Dihydrotestosterone

SIEMENS HEALTHCARE DIAGNOSTICS INC.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Adva Centaur Testosterone Ii (tstii), Adva Centaur Testosterone Ii (tstii) Master Curve Material, Advia Centaur Shbg, Advia Centaur Shbg Calibrator, Advia Centaur Shbg Master Curve Material.

Pre-market Notification Details

Device IDK151986
510k NumberK151986
Device Name:ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 BENEDICT AVENUE Tarrytown,  NY  10591 -5097
ContactMatthew Gee
CorrespondentMatthew Gee
SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 BENEDICT AVENUE Tarrytown,  NY  10591 -5097
Product CodeCDZ  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-17
Decision Date2016-06-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414603407 K151986 000
00630414580654 K151986 000
00630414591131 K151986 000
00630414591148 K151986 000
00630414591155 K151986 000
00630414599854 K151986 000
00630414600215 K151986 000
00630414600222 K151986 000
00630414600239 K151986 000
00630414603391 K151986 000
00630414293752 K151986 000
00630414293813 K151986 000
00630414599861 K151986 000
00630414294285 K151986 000

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