Cleared Special

K082001 - DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
(FDA 510(k) Clearance)

K082001 · Diazyme Laboratories · Toxicology
Dec 2008
Decision
144d
Days
Class 2
Risk

K082001 is an FDA 510(k) clearance for the DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B. This device is classified as a Atomic Absorption, Lithium (Class II — Special Controls, product code JII).

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on December 5, 2008, 144 days after receiving the submission on July 14, 2008.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3560.

Submission Details

510(k) Number K082001 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2008
Decision Date December 05, 2008
Days to Decision 144 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code JII — Atomic Absorption, Lithium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3560