FDA 510(k) Application Details - K962423

Device Classification Name Kit, Fastidious Organisms

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510(K) Number K962423
Device Name Kit, Fastidious Organisms
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 JST
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Date Received 06/24/1996
Decision Date 08/02/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K962423


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