FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K Number: K012287
·
Decision Aug 7, 2001
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
30
Applicant Total
264
Review Days
18
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Basic Information
- Device Name
- MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
- K Number
- K012287
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- July 20, 2001
- Decision Date
- August 7, 2001
- 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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