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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 K921677
Device Name BIOTROL MAGNESIUM (MAGON)
Applicant
Biotrol, USA, Inc.
115 Summit Dr.
Exton,  PA  19341
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
115 Summit Dr.
Exton,  PA  19341
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received04/08/1992
Decision Date 05/26/1992
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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