K864224 is an FDA 510(k) clearance for the ABBOTT SPECTRUM GLUCOSE REAGENT. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on January 5, 1987, 69 days after receiving the submission on October 28, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K864224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1986 |
| Decision Date | January 05, 1987 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |