FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
K Number: K042169
·
Decision Mar 14, 2005
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
47
Review Days
215
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Basic Information
- Device Name
- STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
- K Number
- K042169
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stanbio Laboratory
- Date Received
- August 11, 2004
- Decision Date
- March 14, 2005
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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