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510(k) K083878

LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA by R2 Diagnostics, Inc. — Product Code GIR

K083878 is an FDA 510(k) premarket notification submitted by R2 Diagnostics, Inc. for the device "LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA". The FDA issued a decision of Substantially Equivalent on June 25, 2010. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950. R2 Diagnostics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2010
Date Received
December 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Russel Viper Venom
Device Class
Class I
Regulation Number
864.8950
Review Panel
HE
Submission Type

Other clearances by R2 Diagnostics, Inc.

  • K102908 — NOFACT IX (December 19, 2011)
  • K102851 — NOFACT VIII (December 19, 2011)
  • K090105 — LUPOTEK KCT (December 30, 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 GIR

  • K132130 — REAGENT, RUSSEL VIPER VENOM - LA SCREEN (January 10, 2014)
  • K132076 — REAGENT, RUSSEL VIPER VENOM - LA CONFIRM (January 10, 2014)
  • K110031 — HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (August 24, 2011)
  • K061805 — STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM (December 6, 2006)
  • K000527 — ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 (April 7, 2000)
  • K000528 — ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 (April 7, 2000)
  • K990580 — CRYOCHECK LA SURE, MODEL SUR25-10 (July 28, 1999)
  • K990579 — CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) (July 23, 1999)
  • K990302 — IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADD (April 8, 1999)
  • K940490 — DV TEST AND DVV CONFIRM (April 5, 1995)

FDA data resources