510(k) K141520 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
ALERE I INFLUENZA A & B
| Applicant | Alere Scarborough, Inc D/B/A Binax, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Jun 13, 2014 |
| Received | Jun 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141520
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2017 | Quidel Corporation Influenza Transport Swab Packages, Reference #20171,
One lot with 1010 packages (each package contains 25 transport tubes).
The Influenza Swabs in dry transport tubes are intended for use with influe Terminated |
OCC | None listed |
| Jul 16, 2015 | Alere Scarborough, Inc. dba Binax, Inc. Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024
The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing Terminated |
OCC | None listed |
| May 26, 2015 | Alere Scarborough, Inc. dba Binax, Inc. Alere i Influenza A & B
Product Usage:
The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amp Terminated |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.