Panels › Microbiology › Product code PSZ · Class 2
Devices Detecting Influenza A, B, And C Virus Antigens
Regulation 866.3328
2510(k)s in 12 months (73 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in PSZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2007 | K071657 | TRU FLU Meridian Bioscience, Inc. | PSZ |
| Mar 7, 2007 | K063689 | BD DIRECTIGEN EZ FLU A+B TEST Becton, Dickinson & CO | PSZ |
| Nov 9, 2006 | K062109 | BINAXNOW INFLUENZA A & B TEST Binax, Inc. | PSZ |
| Jun 12, 2006 | K061508 | OSOM INFLUENZA A&B TEST Genzyme Corp. | PSZ |
| Feb 21, 2006 | K051244 | GENZYME OSOM INFLUENZA A & B TEST Genzyme Corp. | PSZ |
| Dec 14, 2005 | K053146 | QUICKVUE INFLUENZA A + B TEST Quidel Corp. | PSZ |
| Nov 30, 2005 | K053126 | BINAXNOW INFLUENZA A & B TEST Binax, Inc. | PSZ |
| Jul 7, 2005 | K042472 | BD DIRECTIGEN EZ FLU A + B Becton, Dickinson & CO | PSZ |
| Mar 16, 2005 | K041626 | IMMUNOCARD STAT! FLU A & B Meridian Bioscience, Inc. | PSZ |
| Aug 10, 2004 | K041049 | BINAXNOW INFLUENZA A & B TEST Binax, Inc. | PSZ |
| Jul 22, 2004 | K041441 | SAS INFLUENZA A TEST Sa Scientific, Inc. | PSZ |
| Jul 22, 2004 | K041439 | SAS INFLUENZA B TEST Sa Scientific, Inc. | PSZ |
| Sep 11, 2003 | K031899 | QUICKVUE INFLUENZA A+B TEST Quidel Corp. | PSZ |
| Jul 17, 2003 | K031565 | XPECT INFLUENZA A/B Remel, Inc. | PSZ |
| Mar 27, 2003 | K023556 | FLU OIA A/B TEST KIT Thermo Biostar, Inc. | PSZ |
| Sep 19, 2002 | K021649 | BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK Binax, Inc. | PSZ |
| Sep 19, 2002 | K021646 | BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK Binax, Inc. | PSZ |
| Nov 30, 2001 | K011684 | INFLUENZA A/B RAPID TEST, CAT NO 2158 663 Roche Diagnostics Corp. | PSZ |
| Jun 28, 2000 | K001364 | BD DIRECTIGEN FLU A+B Bd Becton Dickinson Vacutainer Systems Preanalytic | PSZ |
| Dec 20, 1999 | K993048 | ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST Roche Diagnostics Corp. | PSZ |
| Sep 24, 1999 | K991633 | QUICKVUE INFLUENZA A/B TEST Quidel Corp. | PSZ |
| Nov 25, 1998 | K981651 | AB FLU OIA Biostar, Inc. | PSZ |
| Aug 25, 1998 | K982429 | ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES Zymetx, Inc. | PSZ |
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