FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URINE TOTAL PROTEIN CONTROL
K Number: K831526
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
38
Review Days
92
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- URINE TOTAL PROTEIN CONTROL
- K Number
- K831526
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Quantimetrix Corp.
- Date Received
- May 12, 1983
- Decision Date
- August 12, 1983
- Product Code
- JJW
- 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 |
|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJW), ordered by most recent decision date.
UA-Cellular Complete
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUTION CHECK PLUS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UA-CELLULAR COMPLETE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Quantimetrix Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K062942 | QUANTIMETRIX NICOSURE COTININE URINE CONTROL | Oct 30, 2006 | 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 |