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).
Device ID | K003752 |
510k Number | K003752 |
Device Name: | BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | BIOSAFE LABORATORIES, INC. 100 FIELD DRIVE #240 Lake Forest, IL 60045 |
Contact | Jack A Maggiore |
Correspondent | Jack A Maggiore BIOSAFE LABORATORIES, INC. 100 FIELD DRIVE #240 Lake Forest, IL 60045 |
Product Code | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-05 |
Decision Date | 2001-03-23 |