Stat/Pb Reagent

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K843839 ↗

FDA Product Code

DOF

Device Class

Class II

Regulation

21 CFR Part 862.3550

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Tri-Tech, Inc. →

• What is the STAT/PB REAGENT used for?

  The STAT/PB REAGENT is a Class 2 medical device designed for clinical toxicology applications, specifically for use in lead and atomic absorption testing procedures.

• Is the STAT/PB REAGENt reusable or single-use?

  The STAT/PB REAGENT is supplied as a single-use product, meaning it should be used only once and then properly disposed of according to medical waste guidelines.

• What regulatory clearance has the STAT/PB REAGENT received?

  The STAT/PB REAGENT received FDA 510(k) clearance with K number K843839 on January 3, 1985, and is regulated under product code DOF.

• Who manufactures the STAT/PB REAGENT?

  The STAT/PB REAGENT is manufactured by Tri-Tech, Inc., located at 5120 Revere Rd., Durham, NC 27713, USA.