FDA 510(k) Application Details - K962265

Device Classification Name Culture Media, Multiple Biochemical Test

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510(K) Number K962265
Device Name Culture Media, Multiple Biochemical Test
Applicant DYNATECH LABORATORIES, INC.
14340 SULLYFIELD CIRCLE
CHANTILLY, VA 22021 US
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Contact LARRY POOL
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Regulation Number 866.2320

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Classification Product Code JSE
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Date Received 06/12/1996
Decision Date 07/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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