K120199 is an FDA 510(k) clearance for the GLYCOSYLATED HEMOGLOBIN ASSAY. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on October 12, 2012, 263 days after receiving the submission on January 23, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K120199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2012 |
| Decision Date | October 12, 2012 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |