510(k) K081008 ยท DJG Enzyme Immunoassay, Opiates
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
| Applicant | Lin-Zhi International, Inc., Synnyvale CA, US |
| Decision | Substantially Equivalent, Dec 22, 2008 |
| Received | Apr 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2014 | Lin-Zhi International Inc Single Analyte DAU Calibrator (5 mL)
Norbuprenorphine: Cutoff Calibrator;
IVD - for in vitro diagnostic use only;
Lin-Zhi International
Sunnyvale, CA
The Norbuprenorphine Drug of Abuse (DAU) cutoff C Terminated |
DJG | None listed |
| Nov 25, 2013 | Lin-Zhi International Inc Single Analyte Urine DAU Control (5 m L
Norbuprenorphine, Level II control
For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C.
Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine wi Terminated |
LAS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.