510(k) K083746 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
BIOSIGN FLU A+B
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Nov 10, 2010 |
| Received | Dec 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2012 | Princeton Biomeditech Corp Orasure QuickFlu Rapid A+B Test
Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA.
The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and Terminated |
GNX | None listed |
| Aug 31, 2012 | Princeton Biomeditech Corp Poly stat Flu A & B Test
Manufactured for
Polymedco
510 Furnace Dock Road
Cortlandt Manor, NY 10567
Tel 800-431-2123
914-739-5400
Fax 914-739-5890.
The BioSign Flu A + B test is an in vitro Terminated |
GNX | None listed |
| Aug 31, 2012 | Princeton Biomeditech Corp Status Flu A + B Test
Manufactured by
Princeton Bio Meditech Corporation
Monmouth Junction, NJ 08852 USA.
The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type Terminated |
GNX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.