Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos
FDA 510(k) K042476 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK042476
Submission
- Device name
- Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- September 13, 2004
- Decision date
- December 1, 2004
- 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 |
| 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 Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos cleared by the FDA?
Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos (K042476) received a 510(k) decision of Substantially Equivalent on December 1, 2004, 79 days after the submission was received.
What is the product code of K042476?
The FDA product code is LEG – Enzyme Immunoassay, Valproic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3645.