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510(k) K922326

LUPO-TEST REGEANT by Graoipore , Ltd. — Product Code GIR

K922326 is an FDA 510(k) premarket notification submitted by Graoipore , Ltd. for the device "LUPO-TEST REGEANT". The FDA issued a decision of Substantially Equivalent on April 6, 1993. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1993
Date Received
May 11, 1992
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 for product code GIR

  • K132076 — REAGENT, RUSSEL VIPER VENOM - LA CONFIRM (January 10, 2014)
  • K132130 — REAGENT, RUSSEL VIPER VENOM - LA SCREEN (January 10, 2014)
  • K110031 — HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (August 24, 2011)
  • K083878 — LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (June 25, 2010)
  • 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)

FDA data resources