The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Thyroglobulin Antibody Elisa.
| Device ID | K960370 |
| 510k Number | K960370 |
| Device Name: | THYROGLOBULIN ANTIBODY ELISA |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Richard E Greco |
| Correspondent | Richard E Greco IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-25 |
| Decision Date | 1996-06-20 |