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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cresolphthalein Complexone, Calcium
510(k) Number K901226
Device Name CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact C BREWSTER
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact C BREWSTER
Regulation Number862.1145
Classification Product Code
CIC  
Date Received03/14/1990
Decision Date 04/19/1990
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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