510(k) K896294 ยท CEW Radioimmunoassay, Parathyroid Hormone
DSL I-PTH (DSL #8000)
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, Nov 21, 1989 |
| Received | Oct 31, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896294
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2010 | Beckman Coulter Inc. Active INTACT PTH, Part Number: DSL-8000
The DSL-80000 ACTIVE Intact PTH IRMA Kit provides materials for the quantitative measurement of Intact PTH (I-PTH) in serum or plasma. The assay is intended fo Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.