FDA 510(k)

SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST

K-Number: K000350 · 2000-04-11

Decision Date2000-04-11

Product CodeDIO

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE 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 2000-04-11 under 510(k) number K000350. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST?

SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST is a medical device that received FDA 510(k) clearance on 2000-04-11. The listed applicant is Drug Detection Devices, Ltd.. The 510(k) number is K000350.

When did SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST receive FDA 510(k) clearance?

SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST received FDA 510(k) clearance on 2000-04-11, under 510(k) number K000350.

Who is the listed applicant for SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE 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 COCAINE TEST; DRUGSCREEN DIP COCAINE TEST?

The FDA product code for SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST is DIO.

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Other records listing Drug Detection Devices, Ltd. as applicant

K000452SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST K000522SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST K000400SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST K000402SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST K000449SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST K000273SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST

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Related Devices (Code: DIO)

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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.