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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 K901229
Device Name CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact C BREWTER,PHD
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact C BREWTER,PHD
Regulation Number862.1225
Classification Product Code
CGX  
Date Received03/14/1990
Decision Date 05/04/1990
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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