FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIMENSION WHOLE BLOOD CHOLESTEROL
K Number: K880723
·
Decision Nov 8, 1988
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
1
Review Days
259
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Basic Information
- Device Name
- DIMENSION WHOLE BLOOD CHOLESTEROL
- K Number
- K880723
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technimed, Inc.
- Date Received
- February 23, 1988
- Decision Date
- November 8, 1988
- 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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