FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
K Number: K090939
·
Decision Jun 18, 2009
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
93
Applicant Total
183
Review Days
76
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Basic Information
- Device Name
- ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
- K Number
- K090939
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- April 3, 2009
- Decision Date
- June 18, 2009
- Product Code
- DKB
- 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 |
|---|---|---|---|
| DKB | Calibrators, Drug Mixture | FDA class 2 | Clinical Toxicology |
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