Submission Details
| 510(k) Number | K832783 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 1983 |
| Decision Date | November 28, 1983 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K832783 is an FDA 510(k) clearance for the MICRO-SAMPLE OSMOMETER 3M0, a Osmometer For Clinical Use (Class I — General Controls, product code JJM), submitted by Advanced Instruments, Inc.. The FDA issued a Cleared decision on November 28, 1983, 104 days after receiving the submission on August 16, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2730.
| 510(k) Number | K832783 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 1983 |
| Decision Date | November 28, 1983 |
| Days to Decision | 104 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 |