K941394 is an FDA 510(k) clearance for the STAT FAX 2600. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).
Submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on June 3, 1994, 73 days after receiving the submission on March 22, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2750.
| 510(k) Number | K941394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1994 |
| Decision Date | June 03, 1994 |
| Days to Decision | 73 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 |