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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
510(k) Number K883685
Device Name IMMUNO/FEBRILE ANTIGENS
Applicant
Immunostics Co., Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Applicant Contact KENNETH KUPITS
Correspondent
Immunostics Co., Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Correspondent Contact KENNETH KUPITS
Regulation Number866.3550
Classification Product Code
GNC  
Date Received08/29/1988
Decision Date 09/28/1988
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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