510(k) K905425 ยท FRC Indicator, Biological Sterilization Process
SPORVIEW
| Applicant | Spsmedical Supply Corp., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 27, 1992 |
| Received | Dec 4, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2025 | HF Acquisition Co LLC Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600.
Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580 Open, Classified |
FRC | None listed |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020
b. SPORVIEW CULTURE SET SporView Sterilization Biological Indi Open, Classified |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.