FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADVIA IMS CPSA CONTROL
K Number: K061137
·
Decision Jul 6, 2006
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
46
Review Days
73
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Basic Information
- Device Name
- ADVIA IMS CPSA CONTROL
- K Number
- K061137
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- April 24, 2006
- Decision Date
- July 6, 2006
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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