510(k) K041099 ยท FRC Indicator, Biological Sterilization Process
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
| Applicant | Spsmedical Supply Corp., Rush NY, US |
| Decision | Substantially Equivalent, May 6, 2004 |
| Received | Apr 26, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041099
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.