510(k) K913687 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
CHEM-CHEX
| Applicant | Streck Laboratories, Inc., Omaha NE, US |
| Decision | Substantially Equivalent, Sep 19, 1991 |
| Received | Aug 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913687
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712.
Assayed quality control material for use with the Cholestech LDX System. Terminated |
JJY | None listed |
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number 12-713.
Assayed quality control material for use with the Cholestech LDX System. Terminated |
JJY | None listed |
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-982.
Assayed quality control material for use with the Cholestech LDX System. Terminated |
JJY | None listed |
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983.
Assayed quality control material for use with the Cholestech LDX System. Terminated |
JJY | None listed |
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255.
To be used for verifying the reportable range of tests on the Cholestech LDX System. Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.