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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 K936305
Device Name SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
Applicant
RADIOMETER AMERICA, INC.
811 SHARON DR.
WESTLAKE,  OH  44145 -1598
Applicant Contact JENNIFER LORBACH
Correspondent
RADIOMETER AMERICA, INC.
811 SHARON DR.
WESTLAKE,  OH  44145 -1598
Correspondent Contact JENNIFER LORBACH
Regulation Number866.1640
Classification Product Code
JWY  
Date Received12/21/1993
Decision Date 07/13/1995
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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