510(k) K002128 ยท NDR Enzyme Immunoassay, Inhibin-A
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, Dec 5, 2000 |
| Received | Jul 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002128
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2011 | Beckman Coulter Inc. Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1
The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dim Terminated |
NDR | None listed |
| Jul 11, 2011 | Beckman Coulter Inc. Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1
The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of di Terminated |
NDR | None listed |
| Jul 11, 2011 | Beckman Coulter Inc. Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4
The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dim Terminated |
NDR | None listed |
| Jul 11, 2011 | Beckman Coulter Inc. Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-4
The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of di Terminated |
NDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.