FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇪 Ireland
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K Number: K970735
·
Decision Jun 6, 1997
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
116
Review Days
108
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Basic Information
- Device Name
- BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- K Number
- K970735
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- February 18, 1997
- Decision Date
- June 6, 1997
- 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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