The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning 614 Na/k Analyzer.
Device ID | K843530 |
510k Number | K843530 |
Device Name: | CORNING 614 NA/K ANALYZER |
Classification | Electrode, Ion Specific, Sodium |
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 | JGS |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-07 |
Decision Date | 1984-12-11 |