K003346 is an FDA 510(k) clearance for the RANDOX GLUCOSE (GOD/PAP). This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, GB). The FDA issued a Cleared decision on March 15, 2001, 141 days after receiving the submission on October 25, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K003346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 2000 |
| Decision Date | March 15, 2001 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |