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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, Amphetamine
510(k) Number K920507
Device Name EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
Applicant
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Applicant Contact ROGERS, JR.
Correspondent
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Correspondent Contact ROGERS, JR.
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received02/05/1992
Decision Date 02/27/1992
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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