The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for Tsh (microwell) Elisa.
| Device ID | K962216 |
| 510k Number | K962216 |
| Device Name: | TSH (MICROWELL) ELISA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Jay Singh |
| Correspondent | Jay Singh BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-10 |
| Decision Date | 1996-09-19 |