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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Carbonic Anhydrase C, Antigen, Antiserum, Control
510(k) Number K820900
Device Name EMIT URINE METHADONE ASSAY #3E319
Applicant
SYVA CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SYVA CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5200
Classification Product Code
DDE  
Date Received03/31/1982
Decision Date 04/26/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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