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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K021162
Device Name AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
Applicant
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Applicant Contact WILLIAM R GILBERT II
Correspondent
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Correspondent Contact WILLIAM R GILBERT II
Regulation Number864.5425
Classification Product Code
JPA  
Date Received04/11/2002
Decision Date 08/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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