The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Glycosylated Hemoglobin Set.
Device ID | K791777 |
510k Number | K791777 |
Device Name: | CORNING GLYCOSYLATED HEMOGLOBIN SET |
Classification | Assay, Glycosylated Hemoglobin |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LCP |
CFR Regulation Number | 864.7470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-10 |
Decision Date | 1979-11-13 |