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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Alpha-2-Antiplasmin
510(k) Number K850411
Device Name GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
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 Number864.5425
Classification Product Code
LGP  
Date Received02/04/1985
Decision Date 05/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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