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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K944701
Device Name CALIBRATORS
Applicant
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Applicant Contact YUH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Correspondent Contact YUH-GENG TSAY
Regulation Number862.1150
Classification Product Code
JIS  
Date Received09/23/1994
Decision Date 11/21/1994
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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