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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Panels, Test, Susceptibility, Antimicrobial
510(k) Number K010508
Device Name PASCO MIC AND MIC/ID PANELS
Applicant
PASCO LABORATORIES, INC.
12750 WEST 42ND AVE.
WHEAT RIDGE,  CO  80033
Applicant Contact LINDA K DILLON
Correspondent
PASCO LABORATORIES, INC.
12750 WEST 42ND AVE.
WHEAT RIDGE,  CO  80033
Correspondent Contact LINDA K DILLON
Regulation Number866.1640
Classification Product Code
LTT  
Date Received02/21/2001
Decision Date 04/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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