FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
K Number: K081083
·
Decision Dec 19, 2008
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
2
Applicant Total
64
Review Days
247
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Basic Information
- Device Name
- CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
- K Number
- K081083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3840
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thermo Fisher Scientific
- Date Received
- April 16, 2008
- Decision Date
- December 19, 2008
- Product Code
- OAV
- 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 |
|---|---|---|---|
| OAV | Mycophenolic Acid Test System | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAV), ordered by most recent decision date.
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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