K032035 is an FDA 510(k) clearance for the SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI. This device is classified as a Complement C3, Antigen, Antiserum, Control (Class II - Special Controls, product code CZW).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on August 7, 2003, 37 days after receiving the submission on July 1, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K032035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2003 |
| Decision Date | August 07, 2003 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CZW — Complement C3, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |