Synchron Systems Valproic Acid (V-Pa) Reagent
FDA 510(k) K031870 · Beckman Coulter, Inc.
510(k) numberK031870
Submission
- Device name
- Synchron Systems Valproic Acid (V-Pa) Reagent
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- June 17, 2003
- Decision date
- July 15, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| 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 |
| 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 |
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Questions and answers
When was Synchron Systems Valproic Acid (V-Pa) Reagent cleared by the FDA?
Synchron Systems Valproic Acid (V-Pa) Reagent (K031870) received a 510(k) decision of Substantially Equivalent on July 15, 2003, 28 days after the submission was received.
What is the product code of K031870?
The FDA product code is LEG – Enzyme Immunoassay, Valproic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3645.