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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name reagent, russel viper venom
510(k) Number K000528
Device Name ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
Applicant
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Applicant Contact WILLIAM R GILBERT
Correspondent
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Correspondent Contact WILLIAM R GILBERT
Regulation Number864.8950
Classification Product Code
GIR  
Date Received02/17/2000
Decision Date 04/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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