The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Tsh Enzyme Immunoassay Test Kit, Model #bc-1001.
| Device ID | K991146 |
| 510k Number | K991146 |
| Device Name: | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen |
| Correspondent | Robin J 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 | 1999-04-05 |
| Decision Date | 1999-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013170 | K991146 | 000 |
| B24225TSHHUE010 | K991146 | 000 |
| 00840239017826 | K991146 | 000 |
| 00850392007015 | K991146 | 000 |
| 04048474017823 | K991146 | 000 |