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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameRoche Diagnostics Elecsys E170 Modular Analytics Immunoassay Analyzer  
Document NumberK961481
Parent Document NumberK961481
Analyte NameProlactin
Analyte SpecialtyEndocrinology
ComplexityMODERATE
Effective Date06/12/2001
Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K961481
Device Name ELECSYS 2010 ANALYZER
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact JOHN D STEVENS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact JOHN D STEVENS
Regulation Number862.2160
Classification Product Code
JJE  
Date Received04/18/1996
Decision Date 06/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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