FDA 510(k) Application Details - K931414

Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation

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510(K) Number K931414
Device Name Discs, Strips And Reagents, Microorganism Differentiation
Applicant HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA, CA US
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Contact MELISSA M TRAYLOR
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Regulation Number 866.2660

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Classification Product Code JTO
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Date Received 02/11/1993
Decision Date 05/12/1993
Decision SE - Substantially Equivalent
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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