510(k) K051088 ยท DKB Calibrators, Drug Mixture
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
| Applicant | Lin-Zhi International, Inc., Synnyvale CA, US |
| Decision | Substantially Equivalent, Jun 24, 2005 |
| Received | Apr 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2012 | Lin-Zhi International Inc Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box)
For in vitro diagnostic use only.
Lin-Zhi International, Inc..
670 Almanor Ave.
Sunnyvale, CA 94085
intended use: Drug a Terminated |
DKB | None listed |
| Jan 25, 2012 | Lin-Zhi International Inc Multi-Analyte Urine DAU Calibrator (15 mL);
Multi-Analyte,Intermediate Calibrator;
for in-vitro diagnostic use only.
Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphin Terminated |
DKB | None listed |
| Jan 23, 2012 | Lin-Zhi International Inc Multi-Analyte Urine DAU Control (15 mL);
Level 2, For in-vitro diagnostic use only.
Lin-Zhi International, Inc.
670 Almanor Ave.
Sunnyvale, CA 94085
Multi-Analyte Urine Drug of Drug Abuse (DAU) Cont Terminated |
DIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.