510(k) K962126 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
ACS CKMB II IMMUNOASSAY
| Applicant | Ciba Corning Diagnostics Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 21, 1996 |
| Received | Jun 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962126
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CKMB Calibrator, Cat No. 09318028
Product Usage:
For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays. Terminated |
JHS | None listed |
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748
Product Usage:
For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays. Terminated |
JHS | None listed |
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768
Product Usage:
For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unkno Terminated |
JHS | None listed |
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc Atellica IM CKMB Calibrator, Cat No. 10995532
Product Usage:
For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples af Terminated |
JHS | None listed |
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc Atellica IM CKMB Master Curve Material, Cat No. 10995534
Product Usage:
For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown Terminated |
JHS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.