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FDA 510(k) Application Details - K022232
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K022232
Device Name
Single (Specified) Analyte 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
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Classification Product Code
JJX
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More FDA Info for this Product Code
Date Received
07/10/2002
Decision Date
08/01/2002
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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