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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 K981864
Device Name ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
Applicant
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Applicant Contact ELLEN M VOSS
Correspondent
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Correspondent Contact ELLEN M VOSS
Regulation Number862.1660
Classification Product Code
JJX  
Date Received05/27/1998
Decision Date 06/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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