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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K912959
Device Name MICROTRAK MANAGER
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 Number862.2300
Classification Product Code
JJQ  
Date Received07/08/1991
Decision Date 07/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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