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FDA 510(k) Application Details - K021498
Device Classification Name
Enzyme Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K021498
Device Name
Enzyme Controls (Assayed And Unassayed)
Applicant
BIO-RAD
9500 JERONIMO RD.
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact
MARIA ZEBALLOS
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/09/2002
Decision Date
05/24/2002
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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