FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
Cholesterol
K Number: K150654
·
Decision Sep 29, 2015
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
116
Review Days
200
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Basic Information
- Device Name
- Cholesterol
- K Number
- K150654
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- March 13, 2015
- Decision Date
- September 29, 2015
- 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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