K973335 is an FDA 510(k) clearance for the QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE). This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).
Submitted by Zenyx Scientific , Ltd. (Cheadle, Cheshire, GB). The FDA issued a Cleared decision on April 30, 1998, 238 days after receiving the submission on September 4, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2750.
| 510(k) Number | K973335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1997 |
| Decision Date | April 30, 1998 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JQW — Station, Pipetting And Diluting, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2750 |