FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)
K Number: K860048
·
Decision Jan 22, 1986
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
43
Applicant Total
36
Review Days
16
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Basic Information
- Device Name
- DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)
- K Number
- K860048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Clinical Data, Inc.
- Date Received
- January 6, 1986
- Decision Date
- January 22, 1986
- 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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