The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Lactate Dehydrophoretic Assay.
| Device ID | K841433 |
| 510k Number | K841433 |
| Device Name: | CORNING LACTATE DEHYDROPHORETIC ASSAY |
| Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1984-04-06 |
| Decision Date | 1984-05-16 |