Quantimetrix Urine Drugs of Abuse Control

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K873467 ↗

FDA Product Code

DIF

Device Class

Class I

Regulation

21 CFR Part 862.3280

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Quantimetrix Serum Alcohol Control Level 1 and 2

  Class I

  FDA 510(k) K873011 Active Cleared 29 Oct 1987

• Alkphor(Tm) System, Human Serum Alka Phos Isoenzy

  Class I

  FDA 510(k) K883395 Active Cleared 19 Sep 1988

• Quantimetrix Total Creatine Kinase Control

  Class I

  FDA 510(k) K874302 Active Cleared 2 Feb 1988

• Quantimetrix Serum Lipid Control I & II Liquid

  Class I

  FDA 510(k) K861448 Active Cleared 28 Apr 1986

• Quantimetrix Bilirubin Calibrators

  Class II

  FDA 510(k) K895778 Active Cleared 14 Nov 1989

• Lipophor(Tm) Syst, Human Serum Lipoprotein Control

  Class I

  FDA 510(k) K883247 Active Cleared 13 Sep 1988

See all devices from Quantimetrix Medical Industries →