The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Certain -ise.
| Device ID | K851939 |
| 510k Number | K851939 |
| Device Name: | CORNING CERTAIN -ISE |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-03 |
| Decision Date | 1985-06-14 |