FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K090358 |
ABBOTT LABORATORIES INC |
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 |
08/06/2009 |
K964442 |
BAYER CORP. |
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM |
12/18/1996 |
K042807 |
BAYER HEALTHCARE, LLC |
ADVIA IMS VALPROIC ACID METHOD |
02/08/2005 |
K031870 |
BECKMAN COULTER, INC. |
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT |
07/15/2003 |
K961256 |
BECKMAN INSTRUMENTS, INC. |
SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT |
05/15/1996 |
K982880 |
DADE BEHRING, INC. |
DIMENSION(R) VALPROIC (VALP) ACID METHOD |
08/25/1998 |
K002551 |
DADE BEHRING, INC. |
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL |
10/11/2000 |
K000005 |
DIAGNOSTIC PRODUCTS CORP. |
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 |
03/03/2000 |
K961988 |
DIAGNOSTIC REAGENTS, INC. |
VALPROIC ACID EIA TEST |
07/16/1996 |
K042476 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS |
12/01/2004 |
K011649 |
RANDOX LABORATORIES, LTD. |
RANDOX VALPROIC ACID |
01/15/2002 |
K060690 |
ROCHE DIAGNOSTICS CORP. |
ONLINE VALPROIC ACID |
08/08/2006 |
K032049 |
ROCHE DIAGNOSTICS CORP. |
ROCHE ONLINE TDM VALPROIC ACID |
08/22/2003 |
K973581 |
SCHIAPPARELLI BIOSYSTEMS, INC. |
ACE VALPROIC ACID REAGENT, AED CALIBRATORS |
11/12/1997 |
K030405 |
SERADYN |
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 |
04/28/2003 |
K972132 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS |
07/30/1997 |
K011947 |
SYVA CO. |
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL |
07/02/2001 |