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510(k) K021393

PRECISET DAT PLUS by Quantimetrix Corp. — Product Code DKB

K021393 is an FDA 510(k) premarket notification submitted by Quantimetrix Corp. for the device "PRECISET DAT PLUS". The FDA issued a decision of Substantially Equivalent on June 13, 2002. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Quantimetrix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2002
Date Received
May 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
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)
  • K030826 — PRECISET DAT AMPHETAMINE (April 3, 2003)
  • K013662 — MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (March 8, 2002)
  • K010337 — LIPOPRINT SYSTEM, LDL SUBFRACTIONS (July 25, 2001)

Other clearances for product code DKB

  • K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (November 25, 2014)
  • K133710 — LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (February 21, 2014)
  • K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT (December 13, 2012)
  • K092266 — RANDOX METHAMPHETAMINE ASSAY (May 9, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)
  • K090939 — ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLIN (June 18, 2009)
  • K090900 — ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (June 1, 2009)
  • K062162 — DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (September 14, 2006)
  • K062121 — DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) (August 25, 2006)
  • K060645 — PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRAT (May 30, 2006)

FDA data resources