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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Hematology
510(k) Number K852843
Device Name GENERAL DIAGNOSTICS COAG-A-MATE XC
Applicant
Warner-Lambert Co.
201 Tabor Rd.
Morris Plains,  NJ  07950
Applicant Contact LYNN DECARO
Correspondent
Warner-Lambert Co.
201 Tabor Rd.
Morris Plains,  NJ  07950
Correspondent Contact LYNN DECARO
Regulation Number864.1850
Classification Product Code
KQC  
Date Received07/05/1985
Decision Date 08/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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