510(k) K872644 ยท DLJ Calibrators, Drug Specific
INNOFLUOR VANCOMYCIN CALIBRATOR SET
| Applicant | Innotron of Oregon, Inc., Portland OR, US |
| Decision | Substantially Equivalent, Jul 21, 1987 |
| Received | Jul 6, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2011 | Microgenics Corp Multigent Vancomycin Calibrators;
Manufactured by Microgenics Corp, Fremont, CA.
Distributed by: Abbott Diagnostics, Abbott Park, IL
Product Usage:
The Multigent Vancomycin calibrators are intended Terminated |
DLJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.