FDA 510(k) Application Details - K993812

Device Classification Name Culture Media, Non-Propagating Transport

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510(K) Number K993812
Device Name Culture Media, Non-Propagating Transport
Applicant HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA, CA 93455 US
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Contact MELISSA M TAYLOR
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Regulation Number 866.2390

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Classification Product Code JSM
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Date Received 11/10/1999
Decision Date 12/21/1999
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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