K934592 is an FDA 510(k) clearance for the EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR. This device is classified as a Analyzer, Chemistry, Centrifugal, For Clinical Use (Class I - General Controls, product code JJG).
Submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 6, 1994, 194 days after receiving the submission on September 24, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2140.
| 510(k) Number | K934592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1993 |
| Decision Date | April 06, 1994 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2140 |