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510(k) K903037

LUPO-TEST REAGENT by Gradipore , Ltd. — Product Code GIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1990
Date Received
July 11, 1990
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 Gradipore , Ltd.

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  • K992456 — GRADILEIDEN V TEST (December 21, 1999)
  • K922156 — LUCOR CONFIRMATORY REAGENT (April 6, 1993)

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)
  • K083878 — LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (June 25, 2010)
  • K061805 — STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM (December 6, 2006)
  • K000528 — ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 (April 7, 2000)
  • K000527 — ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 (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)