510(k) K043341 ยท NVI Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
| Applicant | Bio-Rad Laboratories, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Oct 27, 2005 |
| Received | Dec 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043341
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2008 | Bio-Rad Laboratories BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is us Terminated |
LKJ | None listed |
| Apr 22, 2008 | Bio-Rad Laboratories Inc BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547 Terminated |
NVI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.