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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameSCHIAPPARELLI BIOSYSTEMS ACE  
Document NumberK950393
Parent Document NumberK950393
Analyte NameFerritin
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date05/19/1995
Device Classification Name Radioimmunoassay (Two-Site Solid Phase), Ferritin
510(k) Number K950393
Device Name ACE(TM) CEDIA(R) FERRITIN ASSAY
Applicant
Schiapparelli Biosystems, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact MARK A SPAIN
Correspondent
Schiapparelli Biosystems, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact MARK A SPAIN
Regulation Number866.5340
Classification Product Code
JMG  
Date Received02/01/1995
Decision Date 05/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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