BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)

Radioimmunoassay, Thyroid-stimulating Hormone

BIOSAFE LABORATORIES, INC.

The following data is part of a premarket notification filed by Biosafe Laboratories, Inc. with the FDA for Biosafe Capillary Blood Transport System For Testing Thyroid Stimulating Hormone (tsh).

Pre-market Notification Details

Device IDK003752
510k NumberK003752
Device Name:BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant BIOSAFE LABORATORIES, INC. 100 FIELD DRIVE #240 Lake Forest,  IL  60045
ContactJack A Maggiore
CorrespondentJack A Maggiore
BIOSAFE LABORATORIES, INC. 100 FIELD DRIVE #240 Lake Forest,  IL  60045
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-05
Decision Date2001-03-23

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