Panels › Clinical Toxicology › Product code LEG · Class 2
Enzyme Immunoassay, Valproic Acid
Regulation 862.3645
0510(k)s in 12 months (35 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in LEG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 2009 | K090358 | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 Abbott Laboratories, Inc. | LEG |
| Aug 8, 2006 | K060690 | ONLINE VALPROIC ACID Roche Diagnostics Corp. | LEG |
| Feb 8, 2005 | K042807 | ADVIA IMS VALPROIC ACID METHOD Bayer Healthcare, LLC | LEG |
| Dec 1, 2004 | K042476 | VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS Ortho-Clinical Diagnostics, Inc. | LEG |
| Aug 22, 2003 | K032049 | ROCHE ONLINE TDM VALPROIC ACID Roche Diagnostics Corp. | LEG |
| Jul 15, 2003 | K031870 | SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT Beckman Coulter, Inc. | LEG |
| Apr 28, 2003 | K030405 | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 Seradyn | LEG |
| Jan 15, 2002 | K011649 | RANDOX VALPROIC ACID Randox Laboratories, Ltd., GB | LEG |
| Jul 2, 2001 | K011947 | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL Syva Co. | LEG |
| Oct 11, 2000 | K002551 | EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL Dade Behring, Inc. | LEG |
| Mar 3, 2000 | K000005 | IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 Diagnostic Products Corp. | LEG |
| Aug 25, 1998 | K982880 | DIMENSION(R) VALPROIC (VALP) ACID METHOD Dade Behring, Inc. | LEG |
| Nov 12, 1997 | K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS Schiapparelli Biosystems, Inc. | LEG |
| Jul 30, 1997 | K972132 | SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS Sigma Diagnostics, Inc. | LEG |
| Dec 18, 1996 | K964442 | VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM Bayer Corp. | LEG |
| Jul 16, 1996 | K961988 | VALPROIC ACID EIA TEST Diagnostic Reagents, Inc. | LEG |
| May 15, 1996 | K961256 | SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT Beckman Instruments, Inc. | LEG |
| Oct 30, 1995 | K953224 | COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID Roche Diagnostic Systems, Inc. | LEG |
| Nov 10, 1994 | K943866 | VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS Sigma Diagnostics, Inc. | LEG |
| Aug 16, 1994 | K941615 | AXSYM VALPROIC ACID Abbott Laboratories | LEG |
| Mar 11, 1994 | K936208 | VALPROIC ACID Seradyn, Inc. | LEG |
| Dec 29, 1993 | K934061 | BIOTRACK VALPROIC ACID TEST CARTRIDGE Biotrack, Inc. | LEG |
| Sep 21, 1993 | K930734 | CEDIA VALPORIC ACID ASSAY Microgenics Corp. | LEG |
| Dec 3, 1992 | K925003 | COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS Roche Diagnostic Systems, Inc. | LEG |
| Oct 26, 1992 | K922844 | BECKMAN VALPROIC ACID REAGENT Beckman Instruments, Inc. | LEG |
| Jul 5, 1991 | K911688 | INNOFLUOR(TM) VALPROIC ACID REAGENT SET Intl. Bioclinical, Inc. | LEG |
| Jun 26, 1990 | K901538 | MODIFIED OPUS VALPROIC ACID TEST SYSTEM Pb Diagnostic Systems, Inc. | LEG |
| Oct 3, 1989 | K895569 | VALPROIC ACID (FPIA) KIT Tudor Laboratories, Inc. | LEG |
| Aug 15, 1989 | K891581 | COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS Roche Diagnostic Systems, Inc. | LEG |
| Jul 29, 1986 | K862652 | EMIT VALPROIC ACID ASSAY Syva Co. | LEG |
| Oct 4, 1983 | K832719 | EMIT AED VALPROIC ACID ASSAY Syva Co. | LEG |
| Apr 12, 1983 | K830789 | AMES TDA VALPROIC ACID TEST Miles Laboratories, Inc. | LEG |
| Oct 27, 1982 | K822933 | SYVA ADVANCE EMIT AED VALPROIC ACID ASSA Syva Co. | LEG |
| Jan 28, 1981 | K803236 | CYBREX VALPROIC ACID Abbott Laboratories | LEG |
| Jun 20, 1980 | K801207 | EMIT VALPROIC ACID ASSAY Syva Co. | LEG |
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