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FDA 510(k) Application Details - K011169
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K011169
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
INTERNATIONAL ENZYMES, INC.
1432-B SOUTH MISSION RD.
FALLBROOK, CA 92028 US
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Contact
CAROL RUGGIERO
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2001
Decision Date
05/18/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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