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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Immunoperoxidase, Chlamydia Spp.
510(k) Number K852869
Device Name SELECTICULT-CHLAMYDIA
Applicant
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Applicant Contact PAUL CAMPOGNONE
Correspondent
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Correspondent Contact PAUL CAMPOGNONE
Regulation Number866.3120
Classification Product Code
LKH  
Date Received07/08/1985
Decision Date 09/19/1985
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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