Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect Ii Mdma Drug Screen Dipstick Test, Model MF22

by Branan Medical Corp. 510(k)

Active United States

510(k) K040203

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK040203	Date25 Mar 2004Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K040203
FDA Product Code: DKZ
Models / Variants: Monitect Mdma Drug Screen Cassette Test, Model MC22
Fastect Ii Mdma Drug Screen Dipstick Test, Model MF22

Device Class: Class II
Regulation: 21 CFR Part 862.3100
Advisory Committee: Clinical Toxicology
FDA Decision: SESE Substantially Equivalent

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