510(k) K113610 ยท LKJ Antinuclear Antibody, Antigen, Control
ANA-SCREEN WITH MDSS
| Applicant | Bio-Rad Laboratories, Benicia CA, US |
| Decision | Substantially Equivalent, Jul 9, 2012 |
| Received | Dec 6, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113610
| 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.