The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Glyc-affin Glycohemoglobin Assay.
| Device ID | K822867 |
| 510k Number | K822867 |
| Device Name: | GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ISOLAB, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-27 |
| Decision Date | 1982-12-03 |