Roche Online TDM Valproic Acid
FDA 510(k) K032049 · Roche Diagnostics Corp.
510(k) numberK032049
Submission
- Device name
- Roche Online TDM Valproic Acid
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- July 2, 2003
- Decision date
- August 22, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LEG – Enzyme Immunoassay, Valproic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3645
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090358 | Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35…LEG · Traditional | Abbott Laboratories, Inc. | 08/06/2009SE |
| K060690 | Online Valproic AcidLEG · Traditional | Roche Diagnostics Corp. | 08/08/2006SE |
| K042807 | Advia Ims Valproic Acid MethodLEG · Traditional | Bayer Healthcare, LLC | 02/08/2005SE |
| K042476 | Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12…LEG · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/01/2004SE |
| K031870 | Synchron Systems Valproic Acid (V-Pa) ReagentLEG · Special | Beckman Coulter, Inc. | 07/15/2003SE |
| K030405 | QMS / Multigent Valproic Acid Reagent, Part #396075LEG · Traditional | Seradyn | 04/28/2003SE |
| K011649 | Randox Valproic AcidLEG · Traditional | Randox Laboratories, Ltd. | 01/15/2002SE |
| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | Syva Co. | 07/02/2001SE |
| K002551 | Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109ULLEG · Traditional | Dade Behring, Inc. | 10/11/2000SE |
| K000005 | Immulite Valproic Acid, Immulite 2000 Valproic Acid, Catalog # LKVA1, LKVA5 & L2KVA2…LEG · Traditional | Diagnostic Products Corp. | 03/03/2000SE |
More from Diagnostic Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Roche Online TDM Valproic Acid cleared by the FDA?
Roche Online TDM Valproic Acid (K032049) received a 510(k) decision of Substantially Equivalent on August 22, 2003, 51 days after the submission was received.
What is the product code of K032049?
The FDA product code is LEG – Enzyme Immunoassay, Valproic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3645.