The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Elisa Plates.
| Device ID | K863789 |
| 510k Number | K863789 |
| Device Name: | CORNING ELISA PLATES |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | CORNING MEDICAL & SCIENTIFIC 275 RIVER ST. Oneonta, NY 13820 |
| Contact | Barbara L Mullin |
| Correspondent | Barbara L Mullin CORNING MEDICAL & SCIENTIFIC 275 RIVER ST. Oneonta, NY 13820 |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-26 |
| Decision Date | 1986-10-03 |