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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K922904
Device Name RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
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 Number862.1660
Classification Product Code
JJX  
Date Received06/16/1992
Decision Date 07/30/1992
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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