K922532 is an FDA 510(k) clearance for the IL TEST GLUCOSE, PN 181633-80. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on September 30, 1992, 125 days after receiving the submission on May 28, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K922532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1992 |
| Decision Date | September 30, 1992 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |