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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 K853592
Device Name MAGNESIUM
Applicant
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Applicant Contact JANUSZ M SZYSZKO
Correspondent
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Correspondent Contact JANUSZ M SZYSZKO
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received08/27/1985
Decision Date 09/16/1985
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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