FDA 510(k)

MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22

K-Number: K040203 · 2004-03-25

Decision Date2004-03-25

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 is the device name listed in this FDA 510(k) record. The listed applicant is Branan Medical Corp.. It received FDA 510(k) clearance on 2004-03-25 under 510(k) number K040203. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22?

MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 is a medical device that received FDA 510(k) clearance on 2004-03-25. The listed applicant is Branan Medical Corp.. The 510(k) number is K040203.

When did MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 receive FDA 510(k) clearance?

MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 received FDA 510(k) clearance on 2004-03-25, under 510(k) number K040203.

Who is the listed applicant for MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22?

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

What is the FDA product code for MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22?

The FDA product code for MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 is DKZ.

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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.