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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Magnesium
510(k) Number K926144
Device Name URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS
Applicant
Heraeus Kulzer, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact MURACA, JR.
Correspondent
Heraeus Kulzer, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact MURACA, JR.
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received12/07/1992
Decision Date 01/27/1993
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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