510(k) K130528 ยท MID System, Test, Anticardiolipin Immunological
BIOPLEX 2200 APLS IGM
| Applicant | Bio-Rad Laboratories, Benicia CA, US |
| Decision | Substantially Equivalent, Oct 21, 2013 |
| Received | Mar 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130528
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2023 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack Open, Classified |
MID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.