510(k) K965152 ยท JSM Culture Media, Non-Propagating Transport
A.C.T. II
| Applicant | Remel Co., Lenexa KS, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Dec 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965152
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2010 | Remel, Inc remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Terminated |
JSM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.