Cleared Traditional

STAT/PB REAGENT

K843839 · Tri-Tech, Inc. · Chemistry
Jan 1985
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K843839 is an FDA 510(k) clearance for the STAT/PB REAGENT, a Lead, Atomic Absorption (Class II — Special Controls, product code DOF), submitted by Tri-Tech, Inc. (Durham, US). The FDA issued a Cleared decision on January 3, 1985, 94 days after receiving the submission on October 1, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3550.

Submission Details

510(k) Number K843839 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1984
Decision Date January 03, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DOF — Lead, Atomic Absorption
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3550