510(k) K070987 ยท NDW Assay, Porphyrin, Spectrophotometry, Lithium
SENTINEL LITHIUM ASSAY
| Applicant | SENTINEL CH. SpA, Milan, IT |
| Decision | Substantially Equivalent, Aug 2, 2007 |
| Received | Apr 6, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2019 | Sentinel CH SpA MULTIGENT Lithium-intended for the quantitation of lithium in
serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer
List Number: 8L25-30 Terminated |
NDW | None listed |
| Jun 28, 2019 | Sentinel CH SpA Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer
List Number: 08P5320 Terminated |
NDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.