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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dye-Indicator, Ph (Urinary, Non-Quantitative)
510(k) Number K962718
Device Name FEMEXAM TESTCARD
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 Number862.1550
Classification Product Code
CEN  
Date Received07/12/1996
Decision Date 02/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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