510(k) K981607 ยท CIB Radioimmunoassay, Angiotensin I And Renin
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, May 27, 1998 |
| Received | May 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2012 | Beckman Coulter Inc. Active Renin IRMA Kit, Part Number DSL25100
Product Usage:
The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is i Terminated |
CIB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.