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510(k) K945855

A-FACT, ABNORMAL FACTOR ASSAY CONTROL by George King Bio-Medical, Inc. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1995
Date Received
November 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by George King Bio-Medical, Inc.

  • K161316 — George King Coumadin Plasma (February 23, 2017)
  • K945854 — B-FACT, BORDERLINE FACTOR ASSAY CONTROL (October 24, 1995)
  • K945857 — PROTEIN C DEFICIENT PLASMA (October 20, 1995)
  • K945856 — POSITIVE LUPUS ANTICOAGULANT PLASMA (October 5, 1995)

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  • K161316 — George King Coumadin Plasma (February 23, 2017)
  • K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (January 5, 2017)
  • K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (June 3, 2016)
  • K150144 — VisuCon-F Low Fibrinogen Control Plasma (March 6, 2016)
  • K142132 — POOL NORM (December 12, 2014)
  • K133582 — HEMOSIL D-DIMER HS 500 CONTROL (August 15, 2014)
  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)