FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K Number: K030616
·
Decision Mar 31, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
82
Applicant Total
107
Review Days
33
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Basic Information
- Device Name
- CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
- K Number
- K030616
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Microgenics Corp.
- Date Received
- February 26, 2003
- Decision Date
- March 31, 2003
- 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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