FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K Number: K012361
·
Decision Nov 29, 2001
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
43
Applicant Total
264
Review Days
127
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Basic Information
- Device Name
- TINA-QUANT COMPLEMENT C3C TEST SYSTEM
- K Number
- K012361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- July 25, 2001
- Decision Date
- November 29, 2001
- Product Code
- CZW
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| CZW | Complement C3, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CZW), ordered by most recent decision date.
SPAPLUS
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N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
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VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
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