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510(k) K964052

HEMOCUE HEMOTROL by Direct Solutions — Product Code GGM

K964052 is an FDA 510(k) premarket notification submitted by Direct Solutions for the device "HEMOCUE HEMOTROL". The FDA issued a decision of Substantially Equivalent on November 6, 1996. The device falls under product code GGM (Control, Hemoglobin), a Class II device regulated under 21 CFR 864.8625. Direct Solutions has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1996
Date Received
September 30, 1996
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 Direct Solutions

  • K963909 — HEMOCUE GLUCOLIN (November 8, 1996)
  • K964053 — HEMOCUE GLUCOTROL (November 1, 1996)
  • K963908 — HEMOCUE HEMOLIN (October 16, 1996)
  • K955340 — EUROTROL GAS - ISE CONTROL (December 26, 1995)

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)
  • K032791 — GLYCOHEMOSURE HBA1C CONTROL (October 30, 2003)
  • K003030 — LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET (November 29, 2000)
  • K993321 — R&D HGB/GLC WHOLE BLOOD CONTROL (November 12, 1999)
  • K963908 — HEMOCUE HEMOLIN (October 16, 1996)
  • K921681 — CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL (November 17, 1992)

FDA data resources