FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme Lipoprotein (a) Assay
K Number: K180074
·
Decision Mar 22, 2018
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
42
Applicant Total
11
Review Days
71
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Basic Information
- Device Name
- Diazyme Lipoprotein (a) Assay
- K Number
- K180074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories, Inc.
- Date Received
- January 10, 2018
- Decision Date
- March 22, 2018
- 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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