K790611 is an FDA 510(k) clearance for the OSMOMETER MODEL 3W11. This device is classified as a Osmometer For Clinical Use (Class I - General Controls, product code JJM).
Submitted by Advanced Instruments, Inc.. The FDA issued a Cleared decision on June 15, 1979, 78 days after receiving the submission on March 29, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2730.
| 510(k) Number | K790611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1979 |
| Decision Date | June 15, 1979 |
| Days to Decision | 78 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 |