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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubella
510(k) Number K875368
Device Name THE DDI SERODOT RUBELLA IGG TEST KIT
Applicant
Disease Detection International, Inc.
17935 Sky Park Cir., Suite
D
Irvine,  CA  92714
Applicant Contact EL-BADRY, PHD
Correspondent
Disease Detection International, Inc.
17935 Sky Park Cir., Suite
D
Irvine,  CA  92714
Correspondent Contact EL-BADRY, PHD
Regulation Number866.3510
Classification Product Code
LFX  
Date Received12/31/1987
Decision Date 03/23/1988
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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