The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Amerlite Free Thyroid Control Sera Lan.4002.
| Device ID | K923165 |
| 510k Number | K923165 |
| Device Name: | AMERLITE FREE THYROID CONTROL SERA LAN.4002 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1992-08-10 |