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FDA 510(k)

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

K-Number: K102342 · 2011-05-05

ApplicantMicrophage, Inc.
Decision Date2011-05-05
Product CodeOUS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

KEYPATH(TM) 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 2011-05-05 under 510(k) number K102342. 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(TM) MRSA/MSSA BLOOD CULTURE TEST- BT?

KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT is a medical device that received FDA 510(k) clearance on 2011-05-05. The listed applicant is Microphage, Inc.. The 510(k) number is K102342.

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

KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT received FDA 510(k) clearance on 2011-05-05, under 510(k) number K102342.

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

The FDA product code for KEYPATH(TM) 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.

K120563KEYPATH 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.

K120563KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BTMicrophage, Inc.

Official Source

View on FDA Database →

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

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