FDA 510(k) Application Details - K030933

Device Classification Name Manual Antimicrobial Susceptibility Test Systems

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510(K) Number K030933
Device Name Manual Antimicrobial Susceptibility Test Systems
Applicant PASCO LABORATORIES, INC.
12750 WEST 42ND AVE.
WHEAT RIDGE, CO 80033 US
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Contact LINDA K SILLON
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Regulation Number 866.1640

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Classification Product Code JWY
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Date Received 03/25/2003
Decision Date 05/01/2003
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



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