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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K893582
Device Name N-A-G TEST KIT
Applicant
PPR DIAGNOSTICS LTD.
7650 PEBBLE DR.
FORT WORTH,  TX  76118
Applicant Contact RICHARD A HAMER
Correspondent
PPR DIAGNOSTICS LTD.
7650 PEBBLE DR.
FORT WORTH,  TX  76118
Correspondent Contact RICHARD A HAMER
Regulation Number862.1225
Classification Product Code
CGX  
Date Received05/09/1989
Decision Date 10/01/1990
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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