510(k) K110534 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Jan 23, 2012 |
| Received | Feb 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110534
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2019 | Randox Laboratories, Limited Randox Liquid Cardiac Controls Catalogue Number CQ5051 Terminated |
JJY | None listed |
| Oct 4, 2019 | Randox Laboratories, Limited Randox Liquid Cardiac Controls Catalogue Number CQ5052. Terminated |
JJY | None listed |
| Oct 4, 2019 | Randox Laboratories, Limited Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. Terminated |
JJY | None listed |
| Mar 15, 2019 | Response Biomedical Corp. Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318)
IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Si Terminated |
JJY | None listed |
| Mar 11, 2019 | Randox Laboratories Ltd. Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053 Terminated |
JJY | None listed |
| Oct 2, 2018 | Randox Laboratories Ltd. Liquid Cardiac Control, CQ5051 Terminated |
JJY | None listed |
| Oct 2, 2018 | Randox Laboratories Ltd. Liquid Cardiac Control, CQ5052 Terminated |
JJY | None listed |
| Oct 2, 2018 | Randox Laboratories Ltd. Liquid Cardiac Control, CQ5053 Terminated |
JJY | None listed |
| Jun 8, 2018 | Randox Laboratories Ltd. Liquid Cardiac Control - Level 3, cat. no. CQ5053
Product Usage:
This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay Terminated |
JJY | None listed |
| Aug 8, 2017 | Randox Laboratories, Limited Liquid Cardiac Control CQ5053 Terminated |
JJY | None listed |
| Sep 16, 2016 | Randox Laboratories The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.