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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameWampole H. Pylori IgG ELISA  
Document NumberK961221
Parent Document NumberK961221
Analyte NameHelicobacter pylori antibodies
Analyte SpecialtyGeneral Immunology
ComplexityHIGH
Effective Date07/18/1997
Device Classification Name Helicobacter Pylori
510(k) Number K961221
Device Name PYLORI IGG ELISA TEST SYSTEM
Applicant
Armkel, LLC
1306f Bailes Ln.
Frederick,  MD  21701
Applicant Contact WILLIAM L BOTELER
Correspondent
Armkel, LLC
1306f Bailes Ln.
Frederick,  MD  21701
Correspondent Contact WILLIAM L BOTELER
Regulation Number866.3110
Classification Product Code
LYR  
Date Received03/20/1996
Decision Date 07/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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