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510(k) K132076

REAGENT, RUSSEL VIPER VENOM - LA CONFIRM by Dsrv, Inc. — Product Code GIR

K132076 is an FDA 510(k) premarket notification submitted by Dsrv, Inc. for the device "REAGENT, RUSSEL VIPER VENOM - LA CONFIRM". The FDA issued a decision of Substantially Equivalent on January 10, 2014. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950. Dsrv, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2014
Date Received
July 3, 2013
Clearance Type
Special
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 Dsrv, Inc.

  • K132130 — REAGENT, RUSSEL VIPER VENOM - LA SCREEN (January 10, 2014)

Other clearances for product code GIR

  • 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)
  • K940490 — DV TEST AND DVV CONFIRM (April 5, 1995)

FDA data resources