MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23— 510(k) K030113

Clearance details

Applicant

Branan Medical Corp.

Product code

Code DJG

Device class

Class 2

Regulation

21 CFR 862.3650

Advisory panel

Clinical Toxicology

Date received

2003-01-13

Decision date

2003-07-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030113.