510(k) K922913 ยท LBZ Enzyme Immunoassay, Quinidine
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
| Applicant | Syva Co., San Jose CA, US |
| Decision | Substantially Equivalent, Aug 24, 1992 |
| Received | Jun 17, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922913
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2026 | Siemens Healthcare Diagnostics, Inc. Syva EMIT 2000 Quinidine Assay
REF: 4Q019UL
Contents: 1x28 mL, 1x14mL Open, Classified |
LBZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.