Emit 2000 Valproic Acid Assay, Model OSR4G229UL
FDA 510(k) K011947 · Syva Co.
510(k) numberK011947
Submission
- Device name
- Emit 2000 Valproic Acid Assay, Model OSR4G229UL
- Applicant
- Syva Co.
Cupertino, CA, US - Received
- June 21, 2001
- Decision date
- July 2, 2001
- 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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| K042807 | Advia Ims Valproic Acid MethodLEG · Traditional | Bayer Healthcare, LLC | 02/08/2005SE |
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| 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 |
| 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 Emit 2000 Valproic Acid Assay, Model OSR4G229UL cleared by the FDA?
Emit 2000 Valproic Acid Assay, Model OSR4G229UL (K011947) received a 510(k) decision of Substantially Equivalent on July 2, 2001, 11 days after the submission was received.
What is the product code of K011947?
The FDA product code is LEG – Enzyme Immunoassay, Valproic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3645.