FDA 510(k) Application Details - K981199

Device Classification Name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

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510(K) Number K981199
Device Name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant DADE MICROSCAN, INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO, CA 95691 US
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Contact SHAROLYN J LENTSCH
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Regulation Number 866.1640

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Classification Product Code LRG
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Date Received 04/02/1998
Decision Date 11/18/1998
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



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