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FDA 510(k) Application Details - K982935
Device Classification Name
Enzyme Immunoassay, Digoxin
More FDA Info for this Device
510(K) Number
K982935
Device Name
Enzyme Immunoassay, Digoxin
Applicant
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA, CA 92822-8000 US
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Contact
LUCINDA STOCKERT
Other 510(k) Applications for this Contact
Regulation Number
862.3320
More FDA Info for this Regulation Number
Classification Product Code
KXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/21/1998
Decision Date
10/14/1998
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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