FDA 510(k) Application Details - K001721

Device Classification Name Panels, Test, Susceptibility, Antimicrobial

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510(K) Number K001721
Device Name Panels, Test, Susceptibility, Antimicrobial
Applicant PASCO LABORATORIES, INC.
12750 WEST 42ND AVE.
WHEAT RIDGE, CO 80033 US
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Contact LINDA K DILLON
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Regulation Number 866.1640

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Classification Product Code LTT
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Date Received 06/06/2000
Decision Date 08/04/2000
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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