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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 K011620
Device Name EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
Applicant
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact CYNTHIA ARREDONDO
Correspondent
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact CYNTHIA ARREDONDO
Regulation Number862.3320
Classification Product Code
LAN  
Date Received05/25/2001
Decision Date 06/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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