FDA 510(k) Application Details - K963508

Device Classification Name Susceptibility Test Discs, Antimicrobial

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510(K) Number K963508
Device Name Susceptibility Test Discs, Antimicrobial
Applicant DIFCO LABORATORIES, INC.
17197 N. LAUREL PARK
SUITE 400
LIVOUIA, MI 48152 US
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Contact DAVID GATES
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Regulation Number 866.1620

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Classification Product Code JTN
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Date Received 09/03/1996
Decision Date 09/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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