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510(k) K012422

K-ASSAY D-DIMER CONTROLS by Kamiya Biomedical Co. — Product Code GGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2001
Date Received
July 30, 2001
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

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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)
  • K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (March 1, 2001)
  • K993332 — GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (February 16, 2000)