The following data is part of a premarket notification filed by Electrophoresis Corp. Of America with the FDA for Enzyme Stabilizing Reagent (esr).
| Device ID | K791656 |
| 510k Number | K791656 |
| Device Name: | ENZYME STABILIZING REAGENT (ESR) |
| Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| Applicant | ELECTROPHORESIS CORP. OF AMERICA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFE |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-21 |
| Decision Date | 1979-09-17 |