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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Rickettsia Serological
510(k) Number K901597
Device Name INDX DIP S TICKS
Applicant
Intercare Diagnostics, Inc.
P.O. Box 24124
Baltimore,  MD  21227
Applicant Contact HELENE PAXTON
Correspondent
Intercare Diagnostics, Inc.
P.O. Box 24124
Baltimore,  MD  21227
Correspondent Contact HELENE PAXTON
Regulation Number866.3500
Classification Product Code
LSQ  
Date Received04/05/1990
Decision Date 12/21/1990
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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