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FDA 510(k)

ONETOUCH REVEAL

K-Number: K132618 · 2013-12-16

ApplicantLifescan, Inc.
Decision Date2013-12-16
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ONETOUCH REVEAL is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 2013-12-16 under 510(k) number K132618. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONETOUCH REVEAL?

ONETOUCH REVEAL is a medical device that received FDA 510(k) clearance on 2013-12-16. The listed applicant is Lifescan, Inc.. The 510(k) number is K132618.

When did ONETOUCH REVEAL receive FDA 510(k) clearance?

ONETOUCH REVEAL received FDA 510(k) clearance on 2013-12-16, under 510(k) number K132618.

Who is the listed applicant for ONETOUCH REVEAL?

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

What is the FDA product code for ONETOUCH REVEAL?

The FDA product code for ONETOUCH REVEAL is MRZ.

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Other records listing Lifescan, 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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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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