The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bioplex 200 Ana Screen On The Bioplex 2200 Multi-analyte Detection System, Model Bioplex 2200.
| Device ID | K041658 |
| 510k Number | K041658 |
| Device Name: | BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond, WA 98052 |
| Contact | Christopher Bensten |
| Correspondent | Christopher Bensten BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond, WA 98052 |
| Product Code | LKJ |
| Subsequent Product Code | LJM |
| Subsequent Product Code | LKO |
| Subsequent Product Code | LLL |
| Subsequent Product Code | LRM |
| Subsequent Product Code | MQA |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-18 |
| Decision Date | 2004-12-20 |
| Summary: | summary |