K000885 is an FDA 510(k) clearance for the DRX HBA1C - FOR PRESCRIPTION HOME USE. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Metrika, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 26, 2000, 190 days after receiving the submission on March 20, 2000.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K000885 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2000 |
| Decision Date | September 26, 2000 |
| Days to Decision | 190 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 |