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DOC: 510(K) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY


 
The Biohit H. pylori IgG antibodies ELISA test was evaluated for clinical sensitivity using a total of 264 samples. The samples were compared to of... Document/File: 510k-substantial-equivalence-determination-decision-summary.pdf, filesize: n/a. Filetype: pdf. Filename: k041238.pdf. Title: 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY. 2014.

 

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  • Filesize: N/A
  • Source: accessdata_dot_fda_dot_gov
  •   Date Archived: 2014-11-10
  •   Author: N/A
 
 
 
 
 

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  510(K) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

... 1 510(K) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(K) NUMBER: K080635 B. PURPOSE FOR SUBMISSION: ...
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