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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 K902581
Device Name EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
Applicant
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Applicant Contact ROGERS, JR.
Correspondent
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Correspondent Contact ROGERS, JR.
Regulation Number862.3200
Classification Product Code
DKB  
Date Received06/11/1990
Decision Date 07/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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