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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf, Psittacosis (Chlamydia Group)
510(k) Number K872700
Device Name YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
Applicant
Sita, Inc.
Regulatory Affairs Department
130 So. Main St.
Allentown,  NJ  08501
Applicant Contact JANIS F CHARLTON
Correspondent
Sita, Inc.
Regulatory Affairs Department
130 So. Main St.
Allentown,  NJ  08501
Correspondent Contact JANIS F CHARLTON
Regulation Number866.3120
Classification Product Code
GPW  
Date Received07/07/1987
Decision Date 10/15/1987
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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