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FDA 510(k)

ALCO TUBE PLUS

K-Number: K082080 · 2009-04-01

ApplicantAlcotest Quebec
Decision Date2009-04-01
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ALCO TUBE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Alcotest Quebec. It received FDA 510(k) clearance on 2009-04-01 under 510(k) number K082080. The device is classified under product code DJZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALCO TUBE PLUS?

ALCO TUBE PLUS is a medical device that received FDA 510(k) clearance on 2009-04-01. The listed applicant is Alcotest Quebec. The 510(k) number is K082080.

When did ALCO TUBE PLUS receive FDA 510(k) clearance?

ALCO TUBE PLUS received FDA 510(k) clearance on 2009-04-01, under 510(k) number K082080.

Who is the listed applicant for ALCO TUBE PLUS?

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

What is the FDA product code for ALCO TUBE PLUS?

The FDA product code for ALCO TUBE PLUS is DJZ.

Related Devices (Code: DJZ)

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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