FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
K Number: K122722
·
Decision Nov 29, 2012
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
42
Applicant Total
183
Review Days
85
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Basic Information
- Device Name
- COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
- K Number
- K122722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- September 5, 2012
- Decision Date
- November 29, 2012
- Product Code
- DFC
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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