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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
Recalls CDRH Recalls
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