The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Glyco-hemoglobin Diagnostic Kit.
| Device ID | K791103 |
| 510k Number | K791103 |
| Device Name: | LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | LEECO DIAGNOSTICS, INC. 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 | 1979-06-13 |
| Decision Date | 1979-06-28 |