K933287 is an FDA 510(k) clearance for the 745 GLYCOMAT. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Drew Scientific , Ltd. (London W4 4ph Uk, GB). The FDA issued a Cleared decision on September 9, 1993, 65 days after receiving the submission on July 6, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K933287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1993 |
| Decision Date | September 09, 1993 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |