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Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151935
510(k) Type
Special
Applicant
ALERE SAN DIEGO, INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/2015
Days to Decision
29 days
Submission Type
Summary

Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151935
510(k) Type
Special
Applicant
ALERE SAN DIEGO, INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/2015
Days to Decision
29 days
Submission Type
Summary