FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TC MATRIX CLINICAL CHEMISTRY ANALYZER
K Number: K073370
·
Decision May 8, 2008
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
51
Review Days
160
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Basic Information
- Device Name
- TC MATRIX CLINICAL CHEMISTRY ANALYZER
- K Number
- K073370
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teco Diagnostics
- Date Received
- November 30, 2007
- Decision Date
- May 8, 2008
- 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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