FDA 510(k) Application Details - K960420

Device Classification Name Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

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510(K) Number K960420
Device Name Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Applicant BECTON DICKINSON MICROBIOLOGY SYSTEMS
P.O. BOX 243
COCKEYSVILLE, MD 21030-0243 US
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Contact JUDITH J SMITH
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Regulation Number 866.1700

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Classification Product Code JTZ
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Date Received 01/29/1996
Decision Date 04/04/1996
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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