FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
K Number: K102772
·
Decision Oct 7, 2011
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
2
Applicant Total
3
Review Days
378
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Basic Information
- Device Name
- DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
- K Number
- K102772
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3840
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Heatlhcare Diagnostics, Inc.
- Date Received
- September 24, 2010
- Decision Date
- October 7, 2011
- Product Code
- OAV
- 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 |
|---|---|---|---|
| OAV | Mycophenolic Acid Test System | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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