510(k) K897045 ยท JOJ Indicator, Physical/Chemical Sterilization Process
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
| Applicant | Edward Weck, Inc., Research Triangle Pa NC, US |
| Decision | Substantially Equivalent, Feb 15, 1990 |
| Received | Dec 19, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897045
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2012 | Steris Corporation Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060
The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chem Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.