Cleared Traditional

LEADCARE BLOOD LEAD TESTING SYSTEM

K971640 · Esa, Inc. · Toxicology
Sep 1997
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K971640 is an FDA 510(k) clearance for the LEADCARE BLOOD LEAD TESTING SYSTEM, a Lead, Atomic Absorption (Class II — Special Controls, product code DOF), submitted by Esa, Inc. (Chelmsford, US). The FDA issued a Cleared decision on September 9, 1997, 130 days after receiving the submission on May 2, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3550.

Submission Details

510(k) Number K971640 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1997
Decision Date September 09, 1997
Days to Decision 130 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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