DeviceClearance

FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD— 510(k) K082508

Substantially Equivalent

Branan Medical Corporation

FDA 510(k) clearance K082508 for FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD, Substantially Equivalent on 2008-11-21. Applicant: Branan Medical Corporation. Device class: 2.

Clearance details

Applicant
Branan Medical Corporation
Product code
Code DJG
Device class
Class 2
Regulation
21 CFR 862.3650
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K082508

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082508.

Data sourced from openFDA. This site is unofficial and independent of the FDA.