K925970 is an FDA 510(k) clearance for the MODEL 3D3 OSMOMETER. This device is classified as a Osmometer For Clinical Use (Class I - General Controls, product code JJM).
Submitted by Advanced Instruments, Inc. (Norwood, US). The FDA issued a Cleared decision on July 9, 1993, 226 days after receiving the submission on November 25, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2730.
| 510(k) Number | K925970 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1992 |
| Decision Date | July 09, 1993 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJM — Osmometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2730 |