The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Amerlex Mab Ft3 Assay.
| Device ID | K922771 |
| 510k Number | K922771 |
| Device Name: | KODAK AMERLEX MAB FT3 ASSAY |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Bradford M Spring |
| Correspondent | Bradford M Spring EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1992-10-14 |