510(k) K904714 ยท CFT Radioimmunoassay, Prolactin (Lactogen)
CIBA CORNING ACS PROLACTIN IMMUNOASSAY
| Applicant | Ciba Corning Diagnostics Corp., East Walpole MA, US |
| Decision | Substantially Equivalent, Nov 7, 1990 |
| Received | Oct 18, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904714
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2012 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B
Catalog Number.
Prolactin:110757 and 110758:
US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack )
OUS: 2 pack REF: 00650577 and Ref: 00654 Terminated |
CFT | None listed |
| Sep 19, 2012 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B
US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack )
OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack)
Product Usage:
ADVIA Centaur CP Terminated |
CGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.