FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT PHENOBARBITAL ASSAY
K Number: K123271
·
Decision Apr 26, 2013
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
34
Applicant Total
107
Review Days
189
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Basic Information
- Device Name
- ABBOTT PHENOBARBITAL ASSAY
- K Number
- K123271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3660
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corp.
- Date Received
- October 19, 2012
- Decision Date
- April 26, 2013
- Product Code
- DLZ
- 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 |
|---|---|---|---|
| DLZ | Enzyme Immunoassay, Phenobarbital | FDA class 2 | Clinical Toxicology |
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