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510(k) K790310

HEMOGLOBIN CONTROLS by Electrophoresis Corp. — Product Code GGM

K790310 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. for the device "HEMOGLOBIN CONTROLS". The FDA issued a decision of Substantially Equivalent on March 21, 1979. The device falls under product code GGM (Control, Hemoglobin), a Class II device regulated under 21 CFR 864.8625. Electrophoresis Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1979
Date Received
February 13, 1979
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 Electrophoresis Corp.

  • K802395 — SPECIAL PROCEDURE AQAROSE FILM (November 26, 1980)
  • K790309 — CPK ISOENZYME SUBSTRATE (April 4, 1979)
  • K790311 — LDH ISOENZYME REAGENT (March 21, 1979)

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)
  • K964052 — HEMOCUE HEMOTROL (November 6, 1996)
  • K963908 — HEMOCUE HEMOLIN (October 16, 1996)

FDA data resources