510(k) K971432 ยท FRC Indicator, Biological Sterilization Process
PROSPORE
| Applicant | Raven Biological Laboratories, Inc., Omaha NE, US |
| Decision | Substantially Equivalent, May 20, 1997 |
| Received | Apr 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971432
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2018 | Mesa Laboratories Bozeman Manufacturing Facility ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471 Terminated |
FRC | None listed |
| Feb 12, 2018 | Mesa Laboratories Bozeman Manufacturing Facility SporAmpule Biological Indicator Catalog Number SPS5-100 Terminated |
FRC | None listed |
| Apr 4, 2016 | Mesa Laboratories Inc ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box.
Product Usage:
Biological indicator f Terminated |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.