K041658 is an FDA 510(k) clearance for the BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200. This device is classified as a Antinuclear Antibody, Antigen, Control (Class II - Special Controls, product code LKJ).
Submitted by Bio-Rad Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on December 20, 2004, 185 days after receiving the submission on June 18, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K041658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2004 |
| Decision Date | December 20, 2004 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |