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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Surrogate
510(k) Number K910255
Device Name FLOW CYTOMETRY FITC/PE COMPENSATION KIT
Applicant
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Applicant Contact PETER A TAKES
Correspondent
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Correspondent Contact PETER A TAKES
Regulation Number862.1150
Classification Product Code
JIW  
Date Received01/22/1991
Decision Date 04/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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