KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT— 510(k) K102342

Name: FDA 510(k) clearance K102342
Creator: U.S. Food and Drug Administration
Published: 2011-05-05

Substantially Equivalent

Microphage, Inc.

FDA 510(k) clearance K102342 for KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT, Substantially Equivalent on 2011-05-05. 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: 2010-08-18
Decision date: 2011-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longmont, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUS

view all

K120563 — KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT2012-03-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.