ST AIA-PACK DHEA-S CALIBRATOR SET

Calibrator, Secondary

Tosoh BioScience, Inc.

The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for St Aia-pack Dhea-s Calibrator Set.

Pre-market Notification Details

Device IDK111762
510k NumberK111762
Device Name:ST AIA-PACK DHEA-S CALIBRATOR SET
ClassificationCalibrator, Secondary
Applicant Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco,  CA  94080
ContactJudith K Ogden
CorrespondentJudith K Ogden
Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco,  CA  94080
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-23
Decision Date2011-08-05
Summary:summary

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