The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for Free T4 Microwell Eia, Model #7019.
| Device ID | K982954 |
| 510k Number | K982954 |
| Device Name: | FREE T4 MICROWELL EIA, MODEL #7019 |
| Classification | Radioimmunoassay, Free Thyroxine |
| 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 | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-24 |
| Decision Date | 1998-09-24 |