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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasminogen, Antigen, Antiserum, Control
510(k) Number K850410
Device Name GEN. DIAG. CHROMOSTRATE PLASMINOGEN 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 Number866.5715
Classification Product Code
DDX  
Date Received02/04/1985
Decision Date 05/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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