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510(k) K061805

STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM by Diagnostica Stago, Inc. — Product Code GIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2006
Date Received
June 27, 2006
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 Diagnostica Stago, Inc.

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  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K151867 — STA R MAX (August 7, 2015)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • K120014 — STA- COAG CONTROL (N+ABN) PLUS (March 14, 2013)
  • K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / (October 26, 2011)
  • K092937 — STA-HYBRID HEP CALIBRATOR (August 2, 2010)
  • K093167 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (December 22, 2009)
  • K092170 — STA LIATEST FREE PS (December 22, 2009)

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)
  • 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)