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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K854619
Device Name DETECTACULT
Applicant
Immunostics Co., Inc.
212 Durham Ave.
Metuchen,  NJ  08840
Applicant Contact KENNETH KUPITS
Correspondent
Immunostics Co., Inc.
212 Durham Ave.
Metuchen,  NJ  08840
Correspondent Contact KENNETH KUPITS
Regulation Number864.6550
Classification Product Code
KHE  
Date Received11/18/1985
Decision Date 03/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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