Submission Details
| 510(k) Number | K962859 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 1996 |
| Decision Date | October 29, 1996 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
K962859 is an FDA 510(k) clearance for the MINI SAMPLE PROCESSOR, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Cavro Scientific Instruments, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 29, 1996, 99 days after receiving the submission on July 22, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.
| 510(k) Number | K962859 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 1996 |
| Decision Date | October 29, 1996 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JQW — Station, Pipetting And Diluting, For Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2750 |