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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, Theophylline
510(k) Number K913123
Device Name EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
Applicant
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Applicant Contact PAUL L ROGERS
Correspondent
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Correspondent Contact PAUL L ROGERS
Regulation Number862.3880
Classification Product Code
KLS  
Date Received07/15/1991
Decision Date 09/19/1991
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
Recalls CDRH Recalls
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