FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
Direct LDL Cholesterol (LDL)
K Number: K161691
·
Decision Mar 20, 2017
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
30
Applicant Total
18
Review Days
273
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Basic Information
- Device Name
- Direct LDL Cholesterol (LDL)
- K Number
- K161691
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Randox Laboratories Limited
- Date Received
- June 20, 2016
- Decision Date
- March 20, 2017
- Product Code
- MRR
- 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 |
|---|---|---|---|
| MRR | System, Test, Low Density, Lipoprotein | FDA class 1 | Clinical Chemistry |
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