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510(k) K032791

GLYCOHEMOSURE HBA1C CONTROL by Quantimetrix Corp. — Product Code GGM

K032791 is an FDA 510(k) premarket notification submitted by Quantimetrix Corp. for the device "GLYCOHEMOSURE HBA1C CONTROL". The FDA issued a decision of Substantially Equivalent on October 30, 2003. The device falls under product code GGM (Control, Hemoglobin), a Class II device regulated under 21 CFR 864.8625. Quantimetrix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2003
Date Received
September 8, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hemoglobin
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
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)
  • K030826 — PRECISET DAT AMPHETAMINE (April 3, 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 GGM

  • K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (November 15, 2019)
  • K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (February 1, 2019)
  • K070546 — LYPHOCHEK DIABETES CONTROL (April 2, 2007)
  • K070334 — R&D SICKLE QC CONTROL (March 29, 2007)
  • K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (November 9, 2005)
  • K003030 — LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET (November 29, 2000)
  • K993321 — R&D HGB/GLC WHOLE BLOOD CONTROL (November 12, 1999)
  • K964052 — HEMOCUE HEMOTROL (November 6, 1996)
  • K963908 — HEMOCUE HEMOLIN (October 16, 1996)
  • K921681 — CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL (November 17, 1992)

FDA data resources