FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Extended Lipid Panel Assay
K Number: K181373
·
Decision Oct 18, 2018
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
1
Review Days
147
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Basic Information
- Device Name
- Extended Lipid Panel Assay
- K Number
- K181373
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Laboratory Corporation of America Holdings
- Date Received
- May 24, 2018
- Decision Date
- October 18, 2018
- Product Code
- CHH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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