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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
510(k) Number K861958
Device Name REPLIANALYZER
Applicant
Mct Medical, Inc.
1997 Sloan Pl.
Suite 26
St. Paul,  MN  55117
Applicant Contact ANN WEAVER
Correspondent
Mct Medical, Inc.
1997 Sloan Pl.
Suite 26
St. Paul,  MN  55117
Correspondent Contact ANN WEAVER
Regulation Number866.1645
Classification Product Code
LON  
Date Received05/20/1986
Decision Date 08/01/1986
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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