510(k) K041658 ยท LKJ Antinuclear Antibody, Antigen, Control
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
| Applicant | Bio-Rad Laboratories, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Dec 20, 2004 |
| Received | Jun 18, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2019 | Bio-Rad Laboratories, Inc. BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101 Terminated |
LKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.