LEG — Enzyme Immunoassay, Valproic Acid Class II
FDA product code LEG covers "Enzyme Immunoassay, Valproic Acid", a Class II medical device regulated under 21 CFR 862.3645. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |