K843997 is an FDA 510(k) clearance for the AO-10 AUTOMATED OSMOMETER. This device is classified as a Osmometer For Clinical Use (Class I - General Controls, product code JJM).
Submitted by bioMerieux, Inc. (Ivyland, US). The FDA issued a Cleared decision on October 31, 1984, 20 days after receiving the submission on October 11, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2730.
| 510(k) Number | K843997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1984 |
| Decision Date | October 31, 1984 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJM — Osmometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2730 |