LEG — Enzyme Immunoassay, Valproic Acid Class II
FDA Device Classification
Classification Details
- Product Code
- LEG
- Device Class
- Class II
- Regulation Number
- 862.3645
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K090358 | abbott laboratories | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODE | August 6, 2009 |
| K060690 | roche diagnostics | ONLINE VALPROIC ACID | August 8, 2006 |
| K042807 | bayer healthcare | ADVIA IMS VALPROIC ACID METHOD | February 8, 2005 |
| K042476 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT | December 1, 2004 |
| K032049 | roche diagnostics | ROCHE ONLINE TDM VALPROIC ACID | August 22, 2003 |
| K031870 | beckman coulter | SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT | July 15, 2003 |
| K030405 | seradyn | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 | April 28, 2003 |
| K011649 | randox laboratories | RANDOX VALPROIC ACID | January 15, 2002 |
| K011947 | syva | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL | July 2, 2001 |
| K002551 | dade behring | EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019U | October 11, 2000 |
| K000005 | diagnostic products | IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2 | March 3, 2000 |
| K982880 | dade behring | DIMENSION(R) VALPROIC (VALP) ACID METHOD | August 25, 1998 |
| K973581 | schiapparelli biosystems | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | November 12, 1997 |
| K972132 | sigma diagnostics | SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACI | July 30, 1997 |
| K964442 | bayer | VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | December 18, 1996 |
| K961988 | diagnostic reagents | VALPROIC ACID EIA TEST | July 16, 1996 |
| K961256 | beckman instruments | SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT | May 15, 1996 |
| K953224 | roche diagnostic systems | COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID | October 30, 1995 |
| K943866 | sigma diagnostics | VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS | November 10, 1994 |
| K941615 | abbott laboratories | AXSYM VALPROIC ACID | August 16, 1994 |