510(k) K050591 ยท FRC Indicator, Biological Sterilization Process
MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS
| Applicant | Raven Biological Laboratories, Inc., Omaha NE, US |
| Decision | Substantially Equivalent, Mar 23, 2005 |
| Received | Mar 8, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | HF Acquisition Co LLC Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS
Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS
Model/Catalog Number: 1023780
Software Version: N/A
Product Description: T Open, Classified |
FRC | None listed |
| Jun 5, 2026 | HF Acquisition Co LLC Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS
Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS
Model/Catalog Number: 1023770
Software Version: N/A
Product Description: T Open, Classified |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.