FDA 510(k) Application Details - K991473

Device Classification Name Reader, Zone, Automated

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510(K) Number K991473
Device Name Reader, Zone, Automated
Applicant INTELLIGENCE ARTIFICIELLE APPLICATIONS
1301 K ST. N.W.
SUITE 1100- EAST TOWER
WASHINGTON, DC 20005 US
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Contact MARC J SCHEINESON
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Regulation Number 866.2850

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Classification Product Code KZK
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Date Received 04/27/1999
Decision Date 11/23/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K991473


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