510(k) K812027 ยท CIW Starch-Dye Bound Polymer, Amylase
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
| Applicant | Eastman Kodak Company, Walker MI, US |
| Decision | Substantially Equivalent, Aug 3, 1981 |
| Received | Jul 20, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage:
For in vitro diagnostic use only to quantitatively measure amylase a Terminated |
CIW | None listed |
| May 11, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase act Terminated |
CIW | None listed |
| May 11, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasm Terminated |
CIW | None listed |
| May 11, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plas Terminated |
CIW | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724
VITROS AMYL Slides quantitatively measure amylase (AMYL) Terminated |
CIW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.