K991483 is an FDA 510(k) clearance for the ABBOTT ARCHITECT GLYCATED HEMOGLOBIN. 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 November 1, 1999, 187 days after receiving the submission on April 28, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K991483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1999 |
| Decision Date | November 01, 1999 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |