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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K992726
Device Name PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS
Applicant
Pasco Laboratories, Inc.
12750 W. 42nd Ave.
Wheat Ridge,  CO  80033
Applicant Contact LINDA K DILLON
Correspondent
Pasco Laboratories, Inc.
12750 W. 42nd Ave.
Wheat Ridge,  CO  80033
Correspondent Contact LINDA K DILLON
Regulation Number866.1620
Classification Product Code
JTN  
Date Received08/13/1999
Decision Date 11/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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