FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COULTER HDL - CHOLESTEROL REAGENT
K Number: K902174
·
Decision Jul 31, 1990
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
51
Review Days
78
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Basic Information
- Device Name
- COULTER HDL - CHOLESTEROL REAGENT
- K Number
- K902174
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Corp.
- Date Received
- May 14, 1990
- Decision Date
- July 31, 1990
- 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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