The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Sensitive Tsh (s-tsh) Enzyme Immunoassay Test Kit; Catalog Number: Bc-1003.
| Device ID | K990993 |
| 510k Number | K990993 |
| Device Name: | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin Hellen |
| Correspondent | Robin Hellen BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-24 |
| Decision Date | 1999-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B24225TSHHUUE010 | K990993 | 000 |
| 00840239017901 | K990993 | 000 |
| 00850392007039 | K990993 | 000 |
| 04048474017908 | K990993 | 000 |