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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mercuric Thiocyanate, Colorimetry, Chloride
510(k) Number K863620
Device Name RAICHEM(TM) CHLORIDE REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Applicant Contact PEACOCK, JR.
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Correspondent Contact PEACOCK, JR.
Regulation Number862.1170
Classification Product Code
CHJ  
Date Received09/16/1986
Decision Date 09/26/1986
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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