K023764 is an FDA 510(k) clearance for the UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100. This device is classified as a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I - General Controls, product code JJE).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on January 28, 2003, 77 days after receiving the submission on November 12, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2160.
| 510(k) Number | K023764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2002 |
| Decision Date | January 28, 2003 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2160 |