FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISET DAT AMPHETAMINE
K Number: K030826
·
Decision Apr 3, 2003
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
38
Review Days
20
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
- PRECISET DAT AMPHETAMINE
- K Number
- K030826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3550
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quantimetrix Corp.
- Date Received
- March 14, 2003
- Decision Date
- April 3, 2003
- Product Code
- DIJ
- 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 |
|---|---|---|---|
| DIJ | Lead, Delta Amino Levulinic Acid | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIJ), ordered by most recent decision date.
View allOther 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 |
| 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 |