K840962 is an FDA 510(k) clearance for the REFLOCHECK-S. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984, 108 days after receiving the submission on March 6, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K840962 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1984 |
| Decision Date | June 22, 1984 |
| Days to Decision | 108 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 |