FDA 510(k) Application Details - K960862

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

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510(K) Number K960862
Device Name Multi-Analyte Controls, All Kinds (Assayed)
Applicant MEDICAL ANALYSIS SYSTEMS, INC.
542 FLYNN RD.
CAMARILLO, CA 93012-8058 US
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Contact KEVIN KENNAN
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Regulation Number 862.1660

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Classification Product Code JJY
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Date Received 03/01/1996
Decision Date 04/03/1996
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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