Immulite Valproic Acid, Immulite 2000 Valproic Acid, Catalog # LKVA1, LKVA5 & L2KVA2, L2KVA6
FDA 510(k) K000005 · Diagnostic Products Corp.
510(k) numberK000005
Submission
- Device name
- Immulite Valproic Acid, Immulite 2000 Valproic Acid, Catalog # LKVA1, LKVA5 & L2KVA2, L2KVA6
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- January 3, 2000
- Decision date
- March 3, 2000
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite Valproic Acid, Immulite 2000 Valproic Acid, Catalog # LKVA1, LKVA5 & L2KVA2, L2KVA6 cleared by the FDA?
Immulite Valproic Acid, Immulite 2000 Valproic Acid, Catalog # LKVA1, LKVA5 & L2KVA2, L2KVA6 (K000005) received a 510(k) decision of Substantially Equivalent on March 3, 2000, 60 days after the submission was received.
What is the product code of K000005?
The FDA product code is LEG – Enzyme Immunoassay, Valproic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3645.