FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AXIOM STABLE II TRIGLYCERIDES TEST
K Number: K842443
·
Decision Sep 13, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
4
Review Days
84
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Basic Information
- Device Name
- AXIOM STABLE II TRIGLYCERIDES TEST
- K Number
- K842443
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Axiom, Inc.
- Date Received
- June 21, 1984
- Decision Date
- September 13, 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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