510(k) K070727 ยท JFY Enzymatic Method, Creatinine
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
| Applicant | Siemens Medical Solutions Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 3, 2007 |
| Received | Mar 15, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070727
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and uri Terminated |
JFY | None listed |
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine f Terminated |
JFY | None listed |
| Jan 24, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 Terminated |
JFY | None listed |
| Jan 24, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 Terminated |
JFY | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA CHEMISTRY ENZYMATIC CREATININE_2 Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.