510(k) K132251 ยท LSL Dna-Reagents, Neisseria
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
| Applicant | Hologic / Gen-Probe Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 17, 2013 |
| Received | Jul 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2018 | Hologic, Inc Hologic Panther(R) Fusion(TM), Catalog number ASY-09600
Product Usage:
The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates Terminated |
NSU | None listed |
| Sep 15, 2017 | Hologic, Inc Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use Terminated |
NSU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.