FDA 510(k)

SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST

K-Number: K000522 · 2000-04-18

Decision Date2000-04-18

Product CodeDIS

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Drug Detection Devices, Ltd.. It received FDA 510(k) clearance on 2000-04-18 under 510(k) number K000522. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST?

SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST is a medical device that received FDA 510(k) clearance on 2000-04-18. The listed applicant is Drug Detection Devices, Ltd.. The 510(k) number is K000522.

When did SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST receive FDA 510(k) clearance?

SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST received FDA 510(k) clearance on 2000-04-18, under 510(k) number K000522.

Who is the listed applicant for SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST?

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

What is the FDA product code for SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST?

The FDA product code for SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST is DIS.

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Other records listing Drug Detection Devices, Ltd. as applicant

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Related Devices (Code: DIS)

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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.