The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for T4 Microwell Eia (enzyme Immunoassay0.
| Device ID | K950588 |
| 510k Number | K950588 |
| Device Name: | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Perry G Rucker |
| Correspondent | Perry G Rucker BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-09 |
| Decision Date | 1995-06-29 |