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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 K920314
Device Name TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)
Applicant
Syntex Corp.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Applicant Contact ROGERS, JR.
Correspondent
Syntex Corp.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Correspondent Contact ROGERS, JR.
Regulation Number862.3150
Classification Product Code
DIS  
Date Received01/23/1992
Decision Date 04/17/1992
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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