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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Ha (Including Ha Control), Rubella
510(k) Number K841174
Device Name RUBELLA ANTIBODY FLUOROIMMUNOASSAY
Applicant
Intl. Diagnostic Technology
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Intl. Diagnostic Technology
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3510
Classification Product Code
GOL  
Date Received03/19/1984
Decision Date 06/07/1984
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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