FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
K Number: K063543
·
Decision Dec 22, 2006
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
264
Review Days
28
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Basic Information
- Device Name
- COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
- K Number
- K063543
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- November 24, 2006
- Decision Date
- December 22, 2006
- Product Code
- CIG
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
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