The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Amerlite Tsh-30 Ultrasensitive Standard Sera.
| Device ID | K922736 |
| 510k Number | K922736 |
| Device Name: | KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Yvonne Adair |
| Correspondent | Yvonne Adair EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1992-07-10 |