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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Ammonia
510(k) Number K864706
Device Name RAICHEM(TM) AMMONIA REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Applicant Contact ALFRED E PEACOCK,JR
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Correspondent Contact ALFRED E PEACOCK,JR
Regulation Number862.1065
Classification Product Code
JIF  
Date Received12/02/1986
Decision Date 01/05/1987
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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