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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 K971591
Device Name INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)
Applicant
David C. Bishop, Ph.D.
605 Dilworth Rd.
Dowingtown,  PA  19335
Applicant Contact DAVID C BISHOP
Correspondent
David C. Bishop, Ph.D.
605 Dilworth Rd.
Dowingtown,  PA  19335
Correspondent Contact DAVID C BISHOP
Regulation Number866.3500
Classification Product Code
LSQ  
Date Received05/01/1997
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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