FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIGLYCERIDES GPO REAGENT
K Number: K843552
·
Decision Sep 26, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
319
Review Days
16
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Basic Information
- Device Name
- TRIGLYCERIDES GPO REAGENT
- K Number
- K843552
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- September 10, 1984
- Decision Date
- September 26, 1984
- 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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