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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 K993755
Device Name EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
Applicant
SYVA CO.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Applicant Contact PAUL L ROGERS
Correspondent
SYVA CO.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Correspondent Contact PAUL L ROGERS
Regulation Number862.3200
Classification Product Code
DKB  
Subsequent Product Code
DIF  
Date Received11/05/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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