The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Alkaline Phosphates Isoenzyme Substrate.
| Device ID | K830118 |
| 510k Number | K830118 |
| Device Name: | ALKALINE PHOSPHATES ISOENZYME SUBSTRATE |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-11 |
| Decision Date | 1983-02-25 |