FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
K Number: K080696
·
Decision Sep 11, 2008
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
43
Applicant Total
883
Review Days
183
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Basic Information
- Device Name
- ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
- K Number
- K080696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- March 12, 2008
- Decision Date
- September 11, 2008
- Product Code
- DIP
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DIP | Enzyme Immunoassay, Diphenylhydantoin | FDA class 2 | Clinical Toxicology |
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