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FDA 510(k) Application Details - K011213
Device Classification Name
Electrode, Ion Specific, Sodium
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510(K) Number
K011213
Device Name
Electrode, Ion Specific, Sodium
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA, CA 92822 US
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Contact
ANNETTE HELLIE
Other 510(k) Applications for this Contact
Regulation Number
862.1665
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Classification Product Code
JGS
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More FDA Info for this Product Code
Date Received
04/20/2001
Decision Date
05/16/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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