K842393 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE. 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 August 16, 1984, 59 days after receiving the submission on June 18, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K842393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1984 |
| Decision Date | August 16, 1984 |
| Days to Decision | 59 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 |