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510(k) K903037

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

K903037 is an FDA 510(k) premarket notification submitted by Gradipore , Ltd. for the device "LUPO-TEST REAGENT". The FDA issued a decision of Substantially Equivalent on December 17, 1990. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950. Gradipore , Ltd. has at least 3 other 510(k) clearances on record.

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.

  • K993332 — GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (February 16, 2000)
  • K992456 — GRADILEIDEN V TEST (December 21, 1999)
  • K922156 — LUCOR CONFIRMATORY REAGENT (April 6, 1993)

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