FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
K Number: K050632
·
Decision May 26, 2005
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
46
Review Days
78
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Basic Information
- Device Name
- ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
- K Number
- K050632
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- March 9, 2005
- Decision Date
- May 26, 2005
- 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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