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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K961191
Device Name COLISCREEN
Applicant
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Applicant Contact MELISSA M TRAYLOR, RAC
Correspondent
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Correspondent Contact MELISSA M TRAYLOR, RAC
Regulation Number866.2660
Classification Product Code
JTO  
Date Received03/26/1996
Decision Date 06/17/1996
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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