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FDA 510(k) Application Details - K030768
Device Classification Name
Enzyme Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K030768
Device Name
Enzyme Controls (Assayed And Unassayed)
Applicant
CLINIQA CORPORATION
1432 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
JJT
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More FDA Info for this Product Code
Date Received
03/11/2003
Decision Date
03/21/2003
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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