FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
K Number: K021316
·
Decision Jul 25, 2002
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
27
Review Days
91
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Basic Information
- Device Name
- ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
- K Number
- K021316
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genzyme Corp.
- Date Received
- April 25, 2002
- Decision Date
- July 25, 2002
- Product Code
- LBS
- 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 |
|---|---|---|---|
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | FDA class 1 | Clinical Chemistry |
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