510(k) K011605 ยท LBZ Enzyme Immunoassay, Quinidine
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
| Applicant | Syva Co., Dade Behring, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jun 12, 2001 |
| Received | May 24, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2026 | Siemens Healthcare Diagnostics, Inc. Beckman Coulter, Emit 2000 Quinidine Assay
REF: OSR4Q229
Contents: R1: 2 x 23 mL;R2 2x13 mL Open, Classified |
LBZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.