FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENZYMATIC CHOLESTEROL REAGENT SET
K Number: K871676
·
Decision May 18, 1987
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
3
Review Days
20
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Basic Information
- Device Name
- ENZYMATIC CHOLESTEROL REAGENT SET
- K Number
- K871676
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Michclone Associates, Inc.
- Date Received
- April 28, 1987
- Decision Date
- May 18, 1987
- 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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