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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Human Globulin, Fta-Abs Test
510(k) Number K843613
Device Name FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
Applicant
Immuno-Products Industries
P.O. Box 286
So. Bound Brook,  NJ  08880
Applicant Contact HOWARD RUBINSTEIN
Correspondent
Immuno-Products Industries
P.O. Box 286
So. Bound Brook,  NJ  08880
Correspondent Contact HOWARD RUBINSTEIN
Regulation Number866.3830
Classification Product Code
GMS  
Date Received09/10/1984
Decision Date 10/31/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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