The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning 902 Sodium Potassium Analyzer.
Device ID | K820629 |
510k Number | K820629 |
Device Name: | CORNING 902 SODIUM POTASSIUM ANALYZER |
Classification | Bathophenanthroline, Colorimetry, Iron (non-heme) |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFM |
CFR Regulation Number | 862.1410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-08 |
Decision Date | 1982-03-25 |