FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTIMETRIX NICOSURE COTININE URINE CONTROL
K Number: K062942
·
Decision Oct 30, 2006
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
82
Applicant Total
38
Review Days
32
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Basic Information
- Device Name
- QUANTIMETRIX NICOSURE COTININE URINE CONTROL
- K Number
- K062942
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Quantimetrix Corp.
- Date Received
- September 28, 2006
- Decision Date
- October 30, 2006
- Product Code
- LAS
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LAS | Drug Specific Control Materials | FDA class 1 | Clinical Toxicology |
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Other Clearances by Quantimetrix Corp.
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|---|---|---|---|
| K142262 | AUTION CHECK PLUS | Apr 10, 2015 | Substantially Equivalent |
| K113177 | COMPLETE D 25-OH VITAMIN D CONTROL | May 10, 2012 | Substantially Equivalent |
| K103744 | DROPPER A1C DIABETES CONTROL | May 12, 2011 | Substantially Equivalent |
| K062751 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER | Oct 3, 2006 | Substantially Equivalent |
| K060417 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | Mar 21, 2006 | Substantially Equivalent |
| K032791 | GLYCOHEMOSURE HBA1C CONTROL | Oct 30, 2003 | Substantially Equivalent |
| K030826 | PRECISET DAT AMPHETAMINE | Apr 3, 2003 | Substantially Equivalent |
| K021393 | PRECISET DAT PLUS | Jun 13, 2002 | Substantially Equivalent |
| K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Mar 8, 2002 | Substantially Equivalent |
| K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Jul 25, 2001 | Substantially Equivalent |