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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K972904
Device Name DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
Applicant
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Applicant Contact CHRISTINE V BEACH
Correspondent
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Correspondent Contact CHRISTINE V BEACH
Regulation Number862.1660
Classification Product Code
JJY  
Subsequent Product Code
LSK  
Date Received08/06/1997
Decision Date 02/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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