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FDA 510(k) Application Details - K983640
Device Classification Name
Calibrator, Primary
More FDA Info for this Device
510(K) Number
K983640
Device Name
Calibrator, Primary
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
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIS
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More FDA Info for this Product Code
Date Received
10/16/1998
Decision Date
12/21/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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