The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Clinical Chem.anal.acid,prostatic Acid Phosphatase.
| Device ID | K914167 |
| 510k Number | K914167 |
| Device Name: | CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE |
| Classification | Acid Phosphatase, Thymolphthale Inmonophosphate |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Norman H.geil |
| Correspondent | Norman H.geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | CKE |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-17 |
| Decision Date | 1992-03-17 |