FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
K Number: K061139
·
Decision Jul 6, 2006
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
46
Review Days
73
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Basic Information
- Device Name
- BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
- K Number
- K061139
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1150
- 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
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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