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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrators, drug mixture
510(k) Number K935192
Device Name EMIT IIC CALIBRATORS
Applicant
SYVA CO.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Applicant Contact PAUL ROGERS
Correspondent
SYVA CO.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Correspondent Contact PAUL ROGERS
Regulation Number862.3200
Classification Product Code
DKB  
Date Received10/26/1993
Decision Date 03/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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