K936285 is an FDA 510(k) clearance for the ABBOTT VISION GLYCATED HB, MODIFICATION. 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 June 9, 1995, 526 days after receiving the submission on December 30, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K936285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1993 |
| Decision Date | June 09, 1995 |
| Days to Decision | 526 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 |