510(k) K102700 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
| Applicant | Alere, San Diego, Dba Biosite INcorporated, Dba IN, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 21, 2010 |
| Received | Sep 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102700
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2015 | Alere San Diego, Inc. Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773.
Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) an Terminated |
JJY | None listed |
| Jan 29, 2013 | Alere San Diego, Inc. Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769
Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of Terminated |
JJY | None listed |
| Jan 29, 2013 | Alere San Diego, Inc. Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770
Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the perform Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.