FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A-GENT TRIGLLYCERIDES GPO
K Number: K874187
·
Decision Jan 21, 1988
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
883
Review Days
99
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Basic Information
- Device Name
- A-GENT TRIGLLYCERIDES GPO
- K Number
- K874187
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- October 14, 1987
- Decision Date
- January 21, 1988
- 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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