510(k) K030768 ยท JJT Enzyme Controls (Assayed And Unassayed)
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
| Applicant | Cliniqa Corporation, Fallbrook CA, US |
| Decision | Substantially Equivalent, Mar 21, 2003 |
| Received | Mar 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2012 | Abbott Point Of Care Inc. Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039)
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number Terminated |
JJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.