510(k) K981054 ยท JOJ Indicator, Physical/Chemical Sterilization Process
BROWNE GA INDICATOR FOR CIDEX PRODUCTS
| Applicant | Albert Browne , Ltd., North Attleboro MA, US |
| Decision | Substantially Equivalent, Dec 7, 1998 |
| Received | Mar 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981054
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2005 | Advanced Sterilization Products Cidexplus Solution Test Strips Terminated |
JOJ | None listed |
| Sep 21, 2004 | Advanced Sterilization Products Gluteraldehyde Concentration Indicators
''Browne GA Indicator for CIDEX PLUS Products'' Terminated |
JOJ | None listed |
| Mar 29, 2003 | Advanced Sterilization Products Cidex Plus Solution Test Strips Terminated |
688 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.