510(k) K032306 ยท MDB System, Blood Culturing
VERSATREK
| Applicant | Trek Diagnostic Systems, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Aug 22, 2003 |
| Received | Jul 25, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032306
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2014 | Remel Inc Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS. Terminated |
MDB | None listed |
| Sep 6, 2012 | Trek Diagnostic Systems VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer
T Terminated |
MDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.