The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Alp Reagent Set, Alkaline Phosphatase.
| Device ID | K781718 |
| 510k Number | K781718 |
| Device Name: | ALP REAGENT SET, ALKALINE PHOSPHATASE |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 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 | 1978-10-11 |
| Decision Date | 1978-11-03 |