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510(k) K151935

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 by Alere San Diego, Incorporated — Product Code LYR

K151935 is an FDA 510(k) premarket notification submitted by Alere San Diego, Incorporated for the device "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". The FDA issued a decision of Substantially Equivalent on August 12, 2015. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2015
Date Received
July 14, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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FDA data resources