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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameTOSOH AIA- 1800  
Document NumberK971103
Parent Document NumberK971103
Analyte NameProstatic acid phosphatase (PAP)
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date12/18/2003
Device Classification Name Fluorometer, For Clinical Use
510(k) Number K971103
Device Name AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
Applicant
Tosoh Medics, Inc.
373 Vintage Park Dr.
Suite D
Foster City,  CA  94404
Applicant Contact LORI ROBINSON
Correspondent
Tosoh Medics, Inc.
373 Vintage Park Dr.
Suite D
Foster City,  CA  94404
Correspondent Contact LORI ROBINSON
Regulation Number862.2560
Classification Product Code
KHO  
Date Received03/26/1997
Decision Date 06/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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