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FDA 510(k) Application Details - K983151
Device Classification Name
Enzyme Immunoassay, Digoxin
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510(K) Number
K983151
Device Name
Enzyme Immunoassay, Digoxin
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA, CA 92822 US
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Contact
RICHARD T ROSS
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Regulation Number
862.3320
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Classification Product Code
KXT
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More FDA Info for this Product Code
Date Received
09/09/1998
Decision Date
11/05/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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