The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Amerlite Ck-mb Control Sera Lan.4413.
| Device ID | K925880 |
| 510k Number | K925880 |
| Device Name: | KODAK AMERLITE CK-MB CONTROL SERA LAN.4413 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-19 |
| Decision Date | 1993-02-05 |