The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Amerlite Prolactin-30 Assay.
| Device ID | K922170 |
| 510k Number | K922170 |
| Device Name: | AMERLITE PROLACTIN-30 ASSAY |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Yvonne E Adair |
| Correspondent | Yvonne E Adair EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-08 |
| Decision Date | 1992-09-02 |