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510(k) K945856

POSITIVE LUPUS ANTICOAGULANT PLASMA by George King Bio-Medical, Inc. — Product Code GGC

K945856 is an FDA 510(k) premarket notification submitted by George King Bio-Medical, Inc. for the device "POSITIVE LUPUS ANTICOAGULANT PLASMA". The FDA issued a decision of Substantially Equivalent on October 5, 1995. The device falls under product code GGC (Control, Plasma, Abnormal), a Class II device regulated under 21 CFR 864.5425. George King Bio-Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1995
Date Received
November 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Plasma, Abnormal
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)
  • K945855 — A-FACT, ABNORMAL FACTOR ASSAY CONTROL (October 24, 1995)
  • K945857 — PROTEIN C DEFICIENT PLASMA (October 20, 1995)

Other clearances for product code GGC

  • K102552 — HEMOSIL LA POSITIVE CONTROL (April 5, 2011)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2 (March 16, 2007)
  • K061803 — STA - CONTROL LA 1+2 (July 28, 2006)
  • K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROL (November 3, 2003)
  • K023312 — CONTROL PLASMA P (November 1, 2002)
  • K020878 — LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (April 15, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K012422 — K-ASSAY D-DIMER CONTROLS (August 21, 2001)
  • K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (March 1, 2001)

FDA data resources