FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
K Number: K062751
·
Decision Oct 3, 2006
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
38
Review Days
19
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Basic Information
- Device Name
- MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
- K Number
- K062751
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Quantimetrix Corp.
- Date Received
- September 14, 2006
- Decision Date
- October 3, 2006
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
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CARDIASURE CARDIAC MARKERS CONTROL
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| K032791 | GLYCOHEMOSURE HBA1C CONTROL | Oct 30, 2003 | Substantially Equivalent |
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| K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Mar 8, 2002 | Substantially Equivalent |
| K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Jul 25, 2001 | Substantially Equivalent |