FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VISION TRIGLYCERIDES
K Number: K850031
·
Decision Feb 4, 1985
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
883
Review Days
28
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Basic Information
- Device Name
- VISION TRIGLYCERIDES
- K Number
- K850031
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- January 7, 1985
- Decision Date
- February 4, 1985
- Product Code
- CDT
- 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | FDA class 1 | Clinical Chemistry |
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