Product code LEG
- Device name
- Enzyme Immunoassay, Valproic Acid
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3645
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090358 | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 | Abbott Laboratories, Inc. | 2009-08-06 |
| K060690 | ONLINE VALPROIC ACID | Roche Diagnostics Corp. | 2006-08-08 |
| K042807 | ADVIA IMS VALPROIC ACID METHOD | Bayer Healthcare, LLC | 2005-02-08 |
| K042476 | VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS | Ortho-Clinical Diagnostics, Inc. | 2004-12-01 |
| K032049 | ROCHE ONLINE TDM VALPROIC ACID | Roche Diagnostics Corp. | 2003-08-22 |
| K031870 | SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT | Beckman Coulter, Inc. | 2003-07-15 |
| K030405 | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 | Seradyn | 2003-04-28 |
| K011649 | RANDOX VALPROIC ACID | Randox Laboratories, Ltd. | 2002-01-15 |
| K011947 | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL | Syva Co. | 2001-07-02 |
| K002551 | EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL | Dade Behring, Inc. | 2000-10-11 |
| K000005 | IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 | Diagnostic Products Corp. | 2000-03-03 |
| K982880 | DIMENSION(R) VALPROIC (VALP) ACID METHOD | Dade Behring, Inc. | 1998-08-25 |
| K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| K972132 | SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS | Sigma Diagnostics, Inc. | 1997-07-30 |
| K964442 | VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1996-12-18 |
| K961988 | VALPROIC ACID EIA TEST | Diagnostic Reagents, Inc. | 1996-07-16 |
| K961256 | SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT | Beckman Instruments, Inc. | 1996-05-15 |
| K953224 | COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID | Roche Diagnostic Systems, Inc. | 1995-10-30 |
| K943866 | VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | 1994-11-10 |
| K941615 | AXSYM VALPROIC ACID | Abbott Laboratories | 1994-08-16 |
| K936208 | VALPROIC ACID | Seradyn, Inc. | 1994-03-11 |
| K934061 | BIOTRACK VALPROIC ACID TEST CARTRIDGE | Biotrack, Inc. | 1993-12-29 |
| K930734 | CEDIA VALPORIC ACID ASSAY | Microgenics Corp. | 1993-09-21 |
| K925003 | COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS | Roche Diagnostic Systems, Inc. | 1992-12-03 |
| K922844 | BECKMAN VALPROIC ACID REAGENT | Beckman Instruments, Inc. | 1992-10-26 |
| K911688 | INNOFLUOR(TM) VALPROIC ACID REAGENT SET | Intl. Bioclinical, Inc. | 1991-07-05 |
| K901538 | MODIFIED OPUS VALPROIC ACID TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-06-26 |
| K895569 | VALPROIC ACID (FPIA) KIT | Tudor Laboratories, Inc. | 1989-10-03 |
| K891581 | COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS | Roche Diagnostic Systems, Inc. | 1989-08-15 |
| K862652 | EMIT VALPROIC ACID ASSAY | Syva Co. | 1986-07-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04015630915989 | Free Valproic Acid Controls | Roche Diagnostics GmbH | 2021-06-11 |
| 07613336121610 | Valproic Acid | Roche Diagnostics GmbH | 2020-03-05 |
| 07613336157794 | Valproic Acid | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740154158 | Alinity | ABBOTT LABORATORIES | 2018-12-12 |
| 00630414596013 | Atellica CH VPA | Siemens Healthcare Diagnostics Inc. | 2017-12-27 |
| 00884883001305 | CEDIA Valproic Acid II Assay | Microgenics Corporation | 2016-09-30 |
| 00842768000942 | Syva® Emit® 2000 Valproic Acid Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414964850 | IMMULITE®/IMMULITE® 1000 Systems VAL Valproic Acid | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414962290 | IMMULITE® 2000 Systems VAL Valproic Acid | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414561950 | ADVIA® Chemistry VPA_2 Valproic Acid_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023248 | Emit® 2000 Valproic Acid | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015526 | Dimension Vista® Flex® reagent cartridge VALP | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005718 | Dimension® Flex® reagent cartridge VALP | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 05055273206456 | VPA | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 04015630999385 | Valproic Acid | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630998913 | Valproic Acid | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630997954 | Valproic Acid ONLINE TDM Valproic Acid | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630915958 | Valproic Acid | Roche Diagnostics GmbH | 2016-09-20 |
| 10758750006748 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 15099590222178 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 00380740001827 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740000332 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740001810 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |