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FDA 510(k) Application Details - K993473
Device Classification Name
Calibrators, Drug Specific
More FDA Info for this Device
510(K) Number
K993473
Device Name
Calibrators, Drug Specific
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA, CA 92822 US
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Contact
GAIL LEFEBVRE
Other 510(k) Applications for this Contact
Regulation Number
862.3200
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Classification Product Code
DLJ
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More FDA Info for this Product Code
Date Received
10/14/1999
Decision Date
11/26/1999
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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