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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 K920569
Device Name INDXTM DIP-S-TICKSTM
Applicant
Intercare Diagnostics, Inc.
P.O. Box 24124
Baltimore,  MD  21227
Applicant Contact JEFFREY GIBBS
Correspondent
Intercare Diagnostics, Inc.
P.O. Box 24124
Baltimore,  MD  21227
Correspondent Contact JEFFREY GIBBS
Regulation Number866.3500
Classification Product Code
LSQ  
Date Received02/07/1992
Decision Date 02/09/1993
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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