510(k) K943621 ยท JXB Kit, Identification, Yeast
RAPID YEAST PLUS SYSTEM
| Applicant | Innovative Diagnostic Systems, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, Jan 27, 1995 |
| Received | Jul 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943621
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2013 | Remel Inc remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B.
Product Usage: For the bioch Terminated |
JXB | None listed |
| Feb 26, 2010 | Remel, Inc ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic Terminated |
JXB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.