FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
K Number: K864081
·
Decision Dec 4, 1986
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
22
Review Days
45
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Basic Information
- Device Name
- U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
- K Number
- K864081
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- U. S. Diagnostics, Inc.
- Date Received
- October 20, 1986
- Decision Date
- December 4, 1986
- 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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