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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ph Meter
510(k) Number K952178
Device Name PH-DETECT TEST
Applicant
DIAGNOSTIC REAGENTS, INC.
601 CALIFORNIA AVE.
SUNNYVALE,  CA  94086
Applicant Contact YUH-GENG TSAY
Correspondent
DIAGNOSTIC REAGENTS, INC.
601 CALIFORNIA AVE.
SUNNYVALE,  CA  94086
Correspondent Contact YUH-GENG TSAY
Regulation Number862.2050
Classification Product Code
JQY  
Date Received05/09/1995
Decision Date 10/20/1995
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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