510(k) K952199 ยท CEW Radioimmunoassay, Parathyroid Hormone
ACTIVE INTACT PTH ELISA
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, Jul 17, 1995 |
| Received | May 10, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952199
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2010 | Beckman Coulter Inc. Active I-PTH ELISA, Part Number: DSL-10-8000
The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma Terminated |
CEW | None listed |
| Oct 20, 2010 | Beckman Coulter Inc. Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000
The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measu Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.