The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for T-3 Microwell Eia Model 7013.
| Device ID | K960412 |
| 510k Number | K960412 |
| Device Name: | T-3 MICROWELL EIA MODEL 7013 |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Joseph Irani |
| Correspondent | Joseph Irani BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-29 |
| Decision Date | 1996-03-19 |
| Summary: | summary |