The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slides (uric).
| Device ID | K932728 |
| 510k Number | K932728 |
| Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) |
| Classification | Acid, Uric, Uricase (colorimetric) |
| 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 | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-07 |
| Decision Date | 1994-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750000340 | K932728 | 000 |