510(k) K021449 ยท DLJ Calibrators, Drug Specific
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
| Applicant | Lin-Zhi International, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jun 18, 2002 |
| Received | May 6, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021449
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2014 | Lin-Zhi International Inc Cannabinoids DAU Calibrator Control Level 1
(37.5 ng/mL)
This solution is prepared from non-sterile urine and should be handled as potentially infectious.
IVD;
The Cannabinoids (cTHC also known as T Terminated |
DLJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.