K850930 is an FDA 510(k) clearance for the GLUCOSE. This device is classified as a Orthotoluidine, Glucose (Class II - Special Controls, product code CGE).
Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 10, 1985, 95 days after receiving the submission on March 7, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K850930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1985 |
| Decision Date | June 10, 1985 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGE — Orthotoluidine, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |