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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna Probe, Gardnerella Vaginalis
510(k) Number K964015
Device Name INDICARD TEST
Applicant
Litmus Concepts, Inc.
P.O. Box 296
Front Royal,  VA  22630
Applicant Contact SUZANNE PARISIAN
Correspondent
Litmus Concepts, Inc.
P.O. Box 296
Front Royal,  VA  22630
Correspondent Contact SUZANNE PARISIAN
Regulation Number866.2660
Classification Product Code
MJM  
Date Received10/07/1996
Decision Date 06/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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