One Touch— 510(k) K181844

Name: FDA 510(k) clearance K181844
Creator: U.S. Food and Drug Administration
Published: 2019-04-15

Substantially Equivalent

Thai Nippon Rubber Industry Public Company, Ltd.

FDA 510(k) clearance K181844 for One Touch, Substantially Equivalent on 2019-04-15. Applicant: Thai Nippon Rubber Industry Public Company, Ltd.. Device class: 2.

Clearance details

Applicant: Thai Nippon Rubber Industry Public Company, Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2018-07-11
Decision date: 2019-04-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bangkok, TH

Download summary PDF View on FDA.gov ↗

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