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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K912413
Device Name CHEM-LINK DATA BASE MANAGER
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact THOMAS C BREWSTER
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact THOMAS C BREWSTER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received05/31/1991
Decision Date 07/01/1991
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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