The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Calcium Ph Analyzer 634.
| Device ID | K844188 |
| 510k Number | K844188 |
| Device Name: | CORNING CALCIUM PH ANALYZER 634 |
| Classification | Electrode, Ion Specific, Calcium |
| 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 | JFP |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-26 |
| Decision Date | 1985-02-04 |