FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVIA IMS VALPROIC ACID METHOD
K Number: K042807
·
Decision Feb 8, 2005
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
34
Applicant Total
46
Review Days
119
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Basic Information
- Device Name
- ADVIA IMS VALPROIC ACID METHOD
- K Number
- K042807
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- October 12, 2004
- Decision Date
- February 8, 2005
- Product Code
- LEG
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LEG | Enzyme Immunoassay, Valproic Acid | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LEG), ordered by most recent decision date.
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
FDA 510(k)
FDA Class 2
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ONLINE VALPROIC ACID
FDA 510(k)
FDA Class 2
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VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ROCHE ONLINE TDM VALPROIC ACID
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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