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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Mumps Virus
510(k) Number K872699
Device Name MUMPS CF ANTIGEN AND CONTROL ANTIGEN
Applicant
Sita, Inc.
Regulatory Affairs Dept.
130 So. Main St.
Allentown,  NJ  08501
Applicant Contact JANIS F CHARLTON
Correspondent
Sita, Inc.
Regulatory Affairs Dept.
130 So. Main St.
Allentown,  NJ  08501
Correspondent Contact JANIS F CHARLTON
Regulation Number866.3380
Classification Product Code
GRB  
Date Received07/07/1987
Decision Date 09/18/1987
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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