K002799 is an FDA 510(k) clearance for the PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100. This device is classified as a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II - Special Controls, product code CFF).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on October 5, 2000, 27 days after receiving the submission on September 8, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K002799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2000 |
| Decision Date | October 05, 2000 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |