ONETOUCH REVEAL— 510(k) K132618

Substantially Equivalent

Lifescan, Inc.

FDA 510(k) clearance K132618 for ONETOUCH REVEAL, Substantially Equivalent on 2013-12-16. Applicant: Lifescan, Inc.. Device class: 2.

Clearance details

Applicant: Lifescan, Inc.
Product code: Code MRZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2013-08-21
Decision date: 2013-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Lifescan, Inc.

K120558 — ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION2013-02-07
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K082590 — SYMPHONY METER REMOTE2008-12-17
K082513 — ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM2008-10-22
K081318 — ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM2008-06-09

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