FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
K Number: K822417
·
Decision Oct 21, 1982
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
82
Review Days
71
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Basic Information
- Device Name
- NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
- K Number
- K822417
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- August 11, 1982
- Decision Date
- October 21, 1982
- 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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