K791642 is an FDA 510(k) clearance for the A-GENT GLYCOSPEC. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 17, 1979, 55 days after receiving the submission on August 23, 1979.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K791642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1979 |
| Decision Date | October 17, 1979 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |