The following data is part of a premarket notification filed by American Dade with the FDA for Paramax Alkaline Phosphatase Reagent-.
| Device ID | K831480 |
| 510k Number | K831480 |
| Device Name: | PARAMAX ALKALINE PHOSPHATASE REAGENT- |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | AMERICAN DADE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-09 |
| Decision Date | 1983-06-22 |