FDA 510(k) Application Details - K022936

Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)

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510(K) Number K022936
Device Name Multi-Analyte Controls, All Kinds (Assayed)
Applicant CLINIQA CORPORATION
1432 SOUTH MISSION RD.
FALLBROOK, CA 92028 US
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Contact CAROL RUGGIERO
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Regulation Number 862.1660

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Classification Product Code JJY
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Date Received 09/04/2002
Decision Date 10/02/2002
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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