Valproic Acid Eia Test
FDA 510(k) K961988 · Diagnostic Reagents, Inc.
510(k) numberK961988
Submission
- Device name
- Valproic Acid Eia Test
- Applicant
- Diagnostic Reagents, Inc.
Sunnyvale, CA, US - Received
- May 21, 1996
- Decision date
- July 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
| K032049 | Roche Online TDM Valproic AcidLEG · Traditional | Roche Diagnostics Corp. | 08/22/2003SE |
| 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 |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983268 | Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional | 11/18/1998SE |
| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
Questions and answers
When was Valproic Acid Eia Test cleared by the FDA?
Valproic Acid Eia Test (K961988) received a 510(k) decision of Substantially Equivalent on July 16, 1996, 56 days after the submission was received.
What is the product code of K961988?
The FDA product code is LEG – Enzyme Immunoassay, Valproic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3645.