FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
K Number: K061852
·
Decision Sep 22, 2006
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
43
Applicant Total
343
Review Days
84
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Basic Information
- Device Name
- DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
- K Number
- K061852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- June 30, 2006
- Decision Date
- September 22, 2006
- Product Code
- CZW
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| CZW | Complement C3, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CZW), ordered by most recent decision date.
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FDA 510(k)
FDA Class 2
·Immunology
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