The following data is part of a premarket notification filed by Electrophoresis Corp. Of America with the FDA for Alkaline Phosphatase Reagent.
| Device ID | K792551 |
| 510k Number | K792551 |
| Device Name: | ALKALINE PHOSPHATASE REAGENT |
| Classification | Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | ELECTROPHORESIS CORP. OF AMERICA 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CJH |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-10 |
| Decision Date | 1980-01-29 |