510(k) K872349 ยท DLJ Calibrators, Drug Specific
INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET
| Applicant | Innotron of Oregon, Inc., Portland OR, US |
| Decision | Substantially Equivalent, Jul 21, 1987 |
| Received | Jun 3, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872349
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2012 | Microgenics Corp Tobramycin Calibrators, REF 7F93-01;
Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538;
Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064.
.Tobramyci Terminated |
DLJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.