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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K935230
Device Name EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
Applicant
Syva Co.
20400 Mariani Ave.
Cupertino,  CA  95014
Applicant Contact PAUL ROGERS
Correspondent
Syva Co.
20400 Mariani Ave.
Cupertino,  CA  95014
Correspondent Contact PAUL ROGERS
Regulation Number862.3280
Classification Product Code
DIF  
Date Received11/01/1993
Decision Date 01/03/1994
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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