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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Methaqualone
510(k) Number K921013
Device Name SYVA EMIT II METHAQUALONE ASSAY
Applicant
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact ROGER, JR.
Correspondent
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact ROGER, JR.
Regulation Number862.3630
Classification Product Code
KXS  
Date Received03/03/1992
Decision Date 05/13/1992
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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