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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 K844436
Device Name VIROGEN RUBELLA MICROTITER TEST
Applicant
Armkel, LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact STEPHEN C KOLAKOWSK
Correspondent
Armkel, LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact STEPHEN C KOLAKOWSK
Regulation Number866.3510
Classification Product Code
LQN  
Date Received11/16/1984
Decision Date 05/21/1985
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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