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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, Procainamide
510(k) Number K922914
Device Name EMIT 2000 PROCAINAMIDE CALIBRATORS
Applicant
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135 -1500
Applicant Contact ROGERS, JR.
Correspondent
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135 -1500
Correspondent Contact ROGERS, JR.
Regulation Number862.3320
Classification Product Code
LAR  
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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