FDA 510(k) Application Details - K961730

Device Classification Name Gram Positive Identification Panel

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510(K) Number K961730
Device Name Gram Positive Identification Panel
Applicant BECTON DICKINSON MICROBIOLOGY SYSTEMS
P.O. BOX 243
COCKEYSVILLE, MD 21030-0243 US
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Contact VIRGINIA C WEINKNECHT
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Regulation Number 866.2660

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Classification Product Code LQL
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Date Received 05/03/1996
Decision Date 02/04/1997
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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