FDA 510(k) Application Details - K973488

Device Classification Name Susceptibility Test Discs, Antimicrobial

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510(K) Number K973488
Device Name Susceptibility Test Discs, Antimicrobial
Applicant OXOID, LTD.
WADE RD.
BASINGSTOKE, HAMPSHIRE RG24 8PW GB
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Contact ANDY HOLLIGSWORTH
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Regulation Number 866.1620

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Classification Product Code JTN
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Date Received 09/15/1997
Decision Date 10/10/1997
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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