The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for Anti-tpo.
| Device ID | K954256 |
| 510k Number | K954256 |
| Device Name: | ANTI-TPO |
| Classification | Immunochemical, Thyroglobulin Autoantibody |
| Applicant | BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Perry Rucker |
| Correspondent | Perry Rucker BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | JNL |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1995-11-27 |