BIOSIGN FLU A+B
FDA 510(k) clearance K083746 · decided 2010-11-10
Clearance details
- K-number
- K083746
- Device name
- BIOSIGN FLU A+B
- Applicant
- Princeton BioMeditech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-17
- Decision date
- 2010-11-10
- Days to decision
- 693 days
- Clearance type
- Traditional
- Product code
- PSZ
- Device class
- 2
- Regulation number
- 866.3328
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Monmouth Junction, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Princeton BioMeditech Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 1 recall (Z-2306-2012) | Princeton Biomeditech Corp | 2012-08-31 |
| Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, recall (Z-2307-2012) | Princeton Biomeditech Corp | 2012-08-31 |
| Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction recall (Z-2308-2012) | Princeton Biomeditech Corp | 2012-08-31 |