FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS 8000 MODULAR SERIES ANALYZER
K Number: K100853
·
Decision Sep 9, 2010
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
36
Applicant Total
264
Review Days
167
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Basic Information
- Device Name
- COBAS 8000 MODULAR SERIES ANALYZER
- K Number
- K100853
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- March 26, 2010
- Decision Date
- September 9, 2010
- Product Code
- DCF
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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