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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 K922915
Device Name EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
Applicant
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact ROGERS, JR.
Correspondent
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact ROGERS, JR.
Regulation Number862.3320
Classification Product Code
LAN  
Date Received06/17/1992
Decision Date 08/24/1992
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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