The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Alkaline Phosphatase Cat. # 306-22, 306-23.
| Device ID | K875210 |
| 510k Number | K875210 |
| Device Name: | ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-18 |
| Decision Date | 1988-02-02 |