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FDA 510(k)

SMARTCHECK INR SYSTEM

K-Number: K071265 · 2007-11-30

ApplicantInverness Medical Innovations, Inc.
Decision Date2007-11-30
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SMARTCHECK INR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inverness Medical Innovations, Inc.. It received FDA 510(k) clearance on 2007-11-30 under 510(k) number K071265. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTCHECK INR SYSTEM?

SMARTCHECK INR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-30. The listed applicant is Inverness Medical Innovations, Inc.. The 510(k) number is K071265.

When did SMARTCHECK INR SYSTEM receive FDA 510(k) clearance?

SMARTCHECK INR SYSTEM received FDA 510(k) clearance on 2007-11-30, under 510(k) number K071265.

Who is the listed applicant for SMARTCHECK INR SYSTEM?

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

What is the FDA product code for SMARTCHECK INR SYSTEM?

The FDA product code for SMARTCHECK INR SYSTEM is JPA.

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Other records listing Inverness Medical Innovations, 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.

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Related Devices (Code: JPA)

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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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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