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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antistreptolysin - Titer/Streptolysin O Reagent
510(k) Number K894780
Device Name IMMUNO/ASO
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 Number866.3720
Classification Product Code
GTQ  
Date Received07/27/1989
Decision Date 10/16/1989
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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