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FDA 510(k) Application Details - K010693
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K010693
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA, CA 92822 US
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Contact
RICHARD T ROSS, RAC
Other 510(k) Applications for this Contact
Regulation Number
862.1660
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Classification Product Code
JJX
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More FDA Info for this Product Code
Date Received
03/08/2001
Decision Date
04/11/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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