The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slidde.
| Device ID | K820722 |
| 510k Number | K820722 |
| Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | EASTMAN KODAK COMPANY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-16 |
| Decision Date | 1982-04-01 |