K904027 is an FDA 510(k) clearance for the ABBOTT VISION(TM) GLYCATED HB. 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 February 7, 1991, 161 days after receiving the submission on August 30, 1990.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K904027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1990 |
| Decision Date | February 07, 1991 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |