510(k) K861387 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Jun 27, 1986 |
| Received | Apr 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2021 | Ortho Clinical Diagnostics Inc VITROS Chemistry Products CKMB Slides:
(1)VITROS CKMB Slides (60 Slide cartridge)
Product Code:8058232
(2)VITROS CKMB Slides (18 Slide cartridge)
Product Code: 8001133
Quantitatively measure creat Open, Classified |
JHS | None listed |
| Apr 1, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine Terminated |
JHS | None listed |
| Apr 1, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine k Terminated |
JHS | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133
VITROS CK Slides quantitatively measure creatine kinase Terminated |
JHS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.