The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Extachem Clinical Chemistry Slide Digoxin (dgxn).
| Device ID | K942610 |
| 510k Number | K942610 |
| Device Name: | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) |
| Classification | Enzyme Immunoassay, Digitoxin |
| Applicant | EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
| Contact | Yvonne E Middlefell |
| Correspondent | Yvonne E Middlefell EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
| Product Code | LFM |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-02 |
| Decision Date | 1994-10-20 |