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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K920397
Device Name REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
Applicant
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact DONNA L ANDERSON
Correspondent
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact DONNA L ANDERSON
Regulation Number864.7470
Classification Product Code
LCP  
Date Received01/30/1992
Decision Date 08/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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