The following data is part of a premarket notification filed by Clin Tech Diagnostics Corp. with the FDA for Glyco-sep Reagent Test Set.
| Device ID | K820076 |
| 510k Number | K820076 |
| Device Name: | GLYCO-SEP REAGENT TEST SET |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | CLIN TECH DIAGNOSTICS CORP. 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 | 1982-01-12 |
| Decision Date | 1982-02-12 |