K911712 is an FDA 510(k) clearance for the STRATUS(R) AUTOMATED SAMPLE HANDLER. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on May 15, 1991, 28 days after receiving the submission on April 17, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2750.
| 510(k) Number | K911712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1991 |
| Decision Date | May 15, 1991 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQW — Station, Pipetting And Diluting, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2750 |