FDA 510(k) Application Details - K020237

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

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510(K) Number K020237
Device Name Multi-Analyte Controls, All Kinds (Assayed)
Applicant CONSOLIDATED TECHNOLOGY
4401 FREIDRICH LN. BLDG 1
SUITE 100
AUSTIN, TX 78744-1832 US
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Contact CANDICE BETZ
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Regulation Number 862.1660

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Classification Product Code JJY
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Date Received 01/23/2002
Decision Date 03/19/2002
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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