KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT— 510(k) K120563

Name: FDA 510(k) clearance K120563
Creator: U.S. Food and Drug Administration
Published: 2012-03-30

Substantially Equivalent

Microphage, Inc.

FDA 510(k) clearance K120563 for KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT, Substantially Equivalent on 2012-03-30. Applicant: Microphage, Inc.. Device class: 1.

Clearance details

Applicant: Microphage, Inc.
Product code: Code OUS
Device class: Class 1
Regulation: 21 CFR 866.2050
Advisory panel: Microbiology
Date received: 2012-02-24
Decision date: 2012-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longmont, CO, US

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