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510(k) K090105

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

K090105 is an FDA 510(k) premarket notification submitted by R2 Diagnostics, Inc. for the device "LUPOTEK KCT". The FDA issued a decision of Substantially Equivalent on December 30, 2010. The device falls under product code GGW (Test, Time, Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. R2 Diagnostics, Inc. has at least 9 other 510(k) clearances on record.

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.

  • K102908 — NOFACT IX (December 19, 2011)
  • K102851 — NOFACT VIII (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

  • K260551 — HemosIL Factor V Leiden (APC Resistance V) (March 20, 2026)
  • 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)

FDA data resources