Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen Dipcard

• 2 recalls, same reason

  • Terminated Z-3029-2020 FDA Class II ·initiated 18 Aug 2020 ·on shared 510(k) K082508
  • Terminated Z-3030-2020 FDA Class II ·initiated 18 Aug 2020 ·on shared 510(k) K082508

  Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K082508 ↗

FDA Product Code

DJG

Device Class

Class II

Regulation

21 CFR Part 862.3650

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Quicktox Multiple Drug Dipcard Coc/Met/Thc/Amp/Pcp/Bzo/Bar/Mtd/Tca, Model QT61

  Class II

  FDA 510(k) K022355 Active Cleared 30 Jul 2002

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  FDA 510(k) K122752 Active Cleared 30 Jan 2013

• Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21

  Class II

  FDA 510(k) K010734 Active Cleared 30 Jul 2001

• Monitect Barbiturates Drug Screen Test

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  FDA 510(k) K002337 Active Cleared 22 Nov 2000

• Oratect Oral Fluid Drug Screen Devices

  Class II

  FDA 510(k) K103227 Active Cleared 11 Apr 2012

• Branan Medical Corporation Monitect Cocaine Drug Screen Test

  Class II

  FDA 510(k) K002264 Active Cleared 27 Nov 2000

See all devices from Branan Medical Corp. →