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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, Digitoxin
510(k) Number K942619
Device Name EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
Applicant
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161 -9013
Applicant Contact PAUL J ROGERS JR.
Correspondent
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161 -9013
Correspondent Contact PAUL J ROGERS JR.
Regulation Number862.3300
Classification Product Code
LFM  
Date Received05/26/1994
Decision Date 09/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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