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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, Barbiturate
510(k) Number K926068
Device Name EMIT(R) II BARBITURATE ASSAY
Applicant
Syva Co.
P.O. Box 49013
San Jose,  CA  95161 -9013
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
P.O. Box 49013
San Jose,  CA  95161 -9013
Correspondent Contact PAUL L ROGERS
Regulation Number862.3150
Classification Product Code
DIS  
Date Received12/01/1992
Decision Date 01/12/1993
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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