Cleared Special

K052549 - LEADCARE II BLOOD LEAD TESTING SYSTEM
(FDA 510(k) Clearance)

K052549 · Esa Biosciences, Inc. · Chemistry
Oct 2005
Decision
20d
Days
Class 2
Risk

K052549 is an FDA 510(k) clearance for the LEADCARE II BLOOD LEAD TESTING SYSTEM. This device is classified as a Lead, Atomic Absorption (Class II — Special Controls, product code DOF).

Submitted by Esa Biosciences, Inc. (Chelmsford, US). The FDA issued a Cleared decision on October 6, 2005, 20 days after receiving the submission on September 16, 2005.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3550.

Submission Details

510(k) Number K052549 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2005
Decision Date October 06, 2005
Days to Decision 20 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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