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510(k) K030826

PRECISET DAT AMPHETAMINE by Quantimetrix Corp. — Product Code DIJ

K030826 is an FDA 510(k) premarket notification submitted by Quantimetrix Corp. for the device "PRECISET DAT AMPHETAMINE". The FDA issued a decision of Substantially Equivalent on April 3, 2003. The device falls under product code DIJ (Lead, Delta Amino Levulinic Acid), a Class II device regulated under 21 CFR 862.3550. Quantimetrix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2003
Date Received
March 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lead, Delta Amino Levulinic Acid
Device Class
Class II
Regulation Number
862.3550
Review Panel
TX
Submission Type

Other clearances by Quantimetrix Corp.

  • K142262 — AUTION CHECK PLUS (April 10, 2015)
  • K113177 — COMPLETE D 25-OH VITAMIN D CONTROL (May 10, 2012)
  • K103744 — DROPPER A1C DIABETES CONTROL (May 12, 2011)
  • K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL (October 30, 2006)
  • K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (October 3, 2006)
  • K060417 — MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL (March 21, 2006)
  • K032791 — GLYCOHEMOSURE HBA1C CONTROL (October 30, 2003)
  • K021393 — PRECISET DAT PLUS (June 13, 2002)
  • K013662 — MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (March 8, 2002)
  • K010337 — LIPOPRINT SYSTEM, LDL SUBFRACTIONS (July 25, 2001)

Other clearances for product code DIJ

  • K792407 — ELVI-AMINOLEVULINIC ACID (January 16, 1980)

FDA data resources