FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISE COMPENSATOR
K Number: K052193
·
Decision Oct 3, 2005
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
183
Review Days
53
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Basic Information
- Device Name
- ISE COMPENSATOR
- K Number
- K052193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- August 11, 2005
- Decision Date
- October 3, 2005
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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