FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
K Number: K992766
·
Decision Oct 18, 1999
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
30
Applicant Total
27
Review Days
62
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Basic Information
- Device Name
- N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
- K Number
- K992766
- 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
- August 17, 1999
- Decision Date
- October 18, 1999
- Product Code
- MRR
- 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 |
|---|---|---|---|
| MRR | System, Test, Low Density, Lipoprotein | FDA class 1 | Clinical Chemistry |
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