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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Syncytial Virus, Antigen, Antibody, Ifa
510(k) Number K844721
Device Name INNOFLUOR PRIMIDONE
Applicant
Innotron Diagnostics
6-A Faraday
Irvine,  CA  92718
Applicant Contact MARIJA N VALENTEKOV
Correspondent
Innotron Diagnostics
6-A Faraday
Irvine,  CA  92718
Correspondent Contact MARIJA N VALENTEKOV
Regulation Number866.3480
Classification Product Code
LKT  
Date Received12/04/1984
Decision Date 01/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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