Cleared Traditional

DIAZYME LITHIUM ENZYMATIC ASSAY KIT

K033360 · General Atomics · Chemistry
Dec 2003
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K033360 is an FDA 510(k) clearance for the DIAZYME LITHIUM ENZYMATIC ASSAY KIT, a Atomic Absorption, Lithium (Class II — Special Controls, product code JII), submitted by General Atomics (San Diego, US). The FDA issued a Cleared decision on December 23, 2003, 63 days after receiving the submission on October 21, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3560.

Submission Details

510(k) Number K033360 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2003
Decision Date December 23, 2003
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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