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 |