FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL TEST SYSTEM
K Number: K850390
·
Decision Jul 9, 1985
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
2
Review Days
158
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Basic Information
- Device Name
- CHOLESTEROL TEST SYSTEM
- K Number
- K850390
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hans J. Brouwers & Assoc.
- Date Received
- February 1, 1985
- Decision Date
- July 9, 1985
- Product Code
- CHH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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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Other Clearances by Hans J. Brouwers & Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K850391 | PLASMA EXTRACTION SYSTEM | May 10, 1985 | Substantially Equivalent |