Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35
FDA 510(k) K090358 · Abbott Laboratories, Inc.
510(k) numberK090358
Submission
- Device name
- Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35
- Applicant
- Abbott Laboratories, Inc.
Abbott Park, IL, US - Received
- February 12, 2009
- Decision date
- August 6, 2009
- 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
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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 |
| 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 |
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Questions and answers
When was Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35 cleared by the FDA?
Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35 (K090358) received a 510(k) decision of Substantially Equivalent on August 6, 2009, 175 days after the submission was received.
What is the product code of K090358?
The FDA product code is LEG – Enzyme Immunoassay, Valproic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3645.