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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 K854967
Device Name CRITIC - SF, ASSAYED
Applicant
Dimension Diagnostics
361 Windsor Pl.
St. Peters,  MO  63376
Applicant Contact CLYDE E HAM
Correspondent
Dimension Diagnostics
361 Windsor Pl.
St. Peters,  MO  63376
Correspondent Contact CLYDE E HAM
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/11/1985
Decision Date 01/07/1986
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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