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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, N-Acetylprocainamide
510(k) Number K860140
Device Name STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
Applicant
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact KAREN DARCY
Correspondent
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact KAREN DARCY
Regulation Number862.3320
Classification Product Code
LAN  
Date Received01/14/1986
Decision Date 02/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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