FDA 510(k) Application Details - K962630

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

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510(K) Number K962630
Device Name Multi-Analyte Controls, All Kinds (Assayed)
Applicant CASCO STANDARDS
P.O BOX 970
YARMOUTH, ME 04096 US
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Contact CHRISTINE V BEACH
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Regulation Number 862.1660

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Classification Product Code JJY
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Date Received 07/05/1996
Decision Date 07/22/1996
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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