FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
K Number: K072257
·
Decision Jan 30, 2008
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
82
Applicant Total
16
Review Days
170
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Basic Information
- Device Name
- MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
- K Number
- K072257
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- More Diagnostics
- Date Received
- August 13, 2007
- Decision Date
- January 30, 2008
- Product Code
- LAS
- 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 |
|---|---|---|---|
| LAS | Drug Specific Control Materials | FDA class 1 | Clinical Toxicology |
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