FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
K Number: K090358
·
Decision Aug 6, 2009
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
34
Applicant Total
6
Review Days
175
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Basic Information
- Device Name
- ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
- K Number
- K090358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories, Inc.
- Date Received
- February 12, 2009
- Decision Date
- August 6, 2009
- 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.
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