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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 K874822
Device Name RAICHEM(TM) MAGNESIUM REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Applicant Contact ALFRED E PEACOCK,JR
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Correspondent Contact ALFRED E PEACOCK,JR
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received11/24/1987
Decision Date 01/21/1988
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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