FDA 510(k)

ToxCO

K-Number: K173238 · 2019-04-04

Decision Date2019-04-04

Product CodeCCJ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ToxCO is the device name listed in this FDA 510(k) record. The listed applicant is Bedfont Scientific, Ltd.. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K173238. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ToxCO?

ToxCO is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Bedfont Scientific, Ltd.. The 510(k) number is K173238.

When did ToxCO receive FDA 510(k) clearance?

ToxCO received FDA 510(k) clearance on 2019-04-04, under 510(k) number K173238.

Who is the listed applicant for ToxCO?

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

What is the FDA product code for ToxCO?

The FDA product code for ToxCO is CCJ.

Other records listing Bedfont Scientific, Ltd. 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

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