K011465 is an FDA 510(k) clearance for the SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO. This device is classified as a Colorimetry, Acetaminophen (Class II - Special Controls, product code LDP).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on June 8, 2001, 25 days after receiving the submission on May 14, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K011465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2001 |
| Decision Date | June 08, 2001 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LDP — Colorimetry, Acetaminophen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3030 |