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FDA 510(k) Application Details - K000716
Device Classification Name
Fluorometric Method, Cpk Or Isoenzymes
More FDA Info for this Device
510(K) Number
K000716
Device Name
Fluorometric Method, Cpk Or Isoenzymes
Applicant
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318-1084 US
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Contact
ANGELA M BYLAND
Other 510(k) Applications for this Contact
Regulation Number
862.1215
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Classification Product Code
JHX
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More FDA Info for this Product Code
Date Received
03/03/2000
Decision Date
03/20/2000
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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