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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Fluorescent, Rubeola
510(k) Number K853067
Device Name FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT
Applicant
Idt, A Division of Whittaker M.A. Bioproducts
2050 Concourse Dr.
San Jose,  CA  95131
Applicant Contact LOUISE HARRIS
Correspondent
Idt, A Division of Whittaker M.A. Bioproducts
2050 Concourse Dr.
San Jose,  CA  95131
Correspondent Contact LOUISE HARRIS
Regulation Number866.3520
Classification Product Code
GRE  
Date Received07/22/1985
Decision Date 10/22/1985
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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