510(k) K994381 ยท FRC Indicator, Biological Sterilization Process
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
| Applicant | Raven Biological Laboratories, Inc., Omaha NE, US |
| Decision | Substantially Equivalent, Mar 30, 2001 |
| Received | Dec 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2005 | Namsa Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674. Terminated |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.