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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K994200
Device Name ACCESS HYBRITECH PSA QC, MODEL 37209
Applicant
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Applicant Contact MICHELE GUST
Correspondent
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Correspondent Contact MICHELE GUST
Regulation Number862.1660
Classification Product Code
JJX  
Date Received12/13/1999
Decision Date 01/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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