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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 K861185
Device Name THERACHEM-PLUS, TRI-LEVEL TDC (TM)
Applicant
Fisher Scientific Co., LLC
526 Rte. 303
Orangeburg,  NY  10962
Applicant Contact CHARLES B BREUER
Correspondent
Fisher Scientific Co., LLC
526 Rte. 303
Orangeburg,  NY  10962
Correspondent Contact CHARLES B BREUER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/31/1986
Decision Date 05/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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