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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K934380
Device Name PASCO MIC PANELS/ GENT & STREP SYNERGY
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 Number866.1640
Classification Product Code
JWY  
Date Received09/08/1993
Decision Date 01/27/1994
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
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