510(k) K143651 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Mar 18, 2015 |
| Received | Dec 23, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2016 | Focus Diagnostics Inc Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Model Number: MOL2850, MOL1451, MOL1452, MOL1455 Terminated |
PGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.