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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 K854119
Device Name ACCURACY
Applicant
Columbia Diagnostics, Inc.
8001 Research Way
Springfield,  VA  22153
Applicant Contact JOHN INNOCENTI
Correspondent
Columbia Diagnostics, Inc.
8001 Research Way
Springfield,  VA  22153
Correspondent Contact JOHN INNOCENTI
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/09/1985
Decision Date 10/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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