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510(k) K090105

LUPOTEK KCT by R2 Diagnostics, Inc. — Product Code GGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2010
Date Received
January 15, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

Other clearances by R2 Diagnostics, Inc.

  • K102851 — NOFACT VIII (December 19, 2011)
  • K102908 — NOFACT IX (December 19, 2011)
  • K083878 — LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (June 25, 2010)
  • K082631 — THROMBO TEK PSE, MODEL 90-480 (December 17, 2008)
  • K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2 (March 16, 2007)
  • K050817 — T-TEK (December 12, 2005)
  • K042919 — FIBROTEK FIB (November 29, 2004)
  • K040296 — PHOSPHOPLASTIN RL (May 24, 2004)
  • K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE (February 4, 2004)

Other clearances for product code GGW

  • K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHE (May 8, 2009)
  • K060284 — CRYOCHECK CLOT APCR (May 10, 2006)
  • K042762 — PEFAKIT APC-R FACTOR V LEIDEN (December 22, 2004)
  • K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE (February 4, 2004)
  • K992456 — GRADILEIDEN V TEST (December 21, 1999)
  • K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 (January 13, 1999)
  • K963111 — COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S (December 23, 1996)
  • K945940 — COATEST(R) APC(TM) RESISTANCE (August 7, 1995)
  • K941210 — PTT-LT TEST KIT (March 21, 1995)
  • K924370 — STACLOT(R) PNP TEST KIT (August 9, 1993)