510(k) K181029 ยท OZZ Bordetella Pertussis Dna Assay System
Solana Bordetella Complete Assay
| Applicant | Quidel Corporation, Athens OH, US |
| Decision | Substantially Equivalent, Jul 15, 2018 |
| Received | Apr 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2025 | Ortho-Clinical Diagnostics, Inc. Brand Name: Solana Bordetella Complete Assay
Product Name: Solana Bordetella kit
Model/Catalog Number: M308
Software Version: not applicable
Product Description: One sales unit (kit) contains material Open, Classified |
OZZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.