FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
K Number: K903733
·
Decision Jan 15, 1991
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
1
Review Days
152
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Basic Information
- Device Name
- ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
- K Number
- K903733
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Institute For Clinical Applications
- Date Received
- August 16, 1990
- Decision Date
- January 15, 1991
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | FDA class 1 | Clinical Chemistry |
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