510(k) K160724 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 7, 2016 |
| Received | Mar 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160724
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2019 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in th Terminated |
CGS | None listed |
| May 3, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the qu Terminated |
CGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.