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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, Digoxin
510(k) Number K861393
Device Name EMIT COLUMN DIGOXIN ASSAY
Applicant
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Applicant Contact ELEANOR V CHIU
Correspondent
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Correspondent Contact ELEANOR V CHIU
Regulation Number862.3320
Classification Product Code
KXT  
Date Received04/14/1986
Decision Date 05/29/1986
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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