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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Agglutination Assay, Rubella
510(k) Number K031490
Device Name RUBELLACOL
Applicant
Immunostics Inc.,
3505 Sunset Ave.
Ocean,  NJ  07712
Applicant Contact JEFFREY FLEISHMAN
Correspondent
Immunostics Inc.,
3505 Sunset Ave.
Ocean,  NJ  07712
Correspondent Contact JEFFREY FLEISHMAN
Regulation Number866.3510
Classification Product Code
LQN  
Date Received05/12/2003
Decision Date 07/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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