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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 K874772
Device Name DC-TROL LEVEL 1 OR 2
Applicant
DIAGNOSTIC CHEMICALS, LTD. (USA)
435 MAIN ST.
MONROE,  CT  06468
Applicant Contact DAVID TEMPLETON
Correspondent
DIAGNOSTIC CHEMICALS, LTD. (USA)
435 MAIN ST.
MONROE,  CT  06468
Correspondent Contact DAVID TEMPLETON
Regulation Number862.1660
Classification Product Code
JJY  
Date Received11/19/1987
Decision Date 01/05/1988
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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