The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bioplex 2200 Ana Screen With Medical Decision Support Software For Use With Bioplex 2200 Multi-analyte Detection System.
| Device ID | K043341 |
| 510k Number | K043341 |
| Device Name: | BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
| Classification | Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease |
| Applicant | BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond, WA 98052 |
| Contact | Christopher Bentsen |
| Correspondent | Christopher Bentsen BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond, WA 98052 |
| Product Code | NVI |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-03 |
| Decision Date | 2005-10-27 |
| Summary: | summary |