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FDA 510(k)

KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT

K-Number: K120563 · 2012-03-30

ApplicantMicrophage, Inc.
Decision Date2012-03-30
Product CodeOUS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT is the device name listed in this FDA 510(k) record. The listed applicant is Microphage, Inc.. It received FDA 510(k) clearance on 2012-03-30 under 510(k) number K120563. The device is classified under product code OUS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT?

KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT is a medical device that received FDA 510(k) clearance on 2012-03-30. The listed applicant is Microphage, Inc.. The 510(k) number is K120563.

When did KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT receive FDA 510(k) clearance?

KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT received FDA 510(k) clearance on 2012-03-30, under 510(k) number K120563.

Who is the listed applicant for KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT?

The FDA 510(k) record lists Microphage, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT?

The FDA product code for KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT is OUS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Microphage, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102342KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT

Related Devices (Code: OUS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102342KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BTMicrophage, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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