DIAZYME LITHIUM ENZYMATIC ASSAY KIT— 510(k) K033360

Name: FDA 510(k) clearance K033360
Creator: U.S. Food and Drug Administration
Published: 2003-12-23

Substantially Equivalent

General Atomics

FDA 510(k) clearance K033360 for DIAZYME LITHIUM ENZYMATIC ASSAY KIT, Substantially Equivalent on 2003-12-23. Applicant: General Atomics. Device class: 2.

Clearance details

Applicant: General Atomics
Product code: Code JII
Device class: Class 2
Regulation: 21 CFR 862.3560
Advisory panel: Clinical Toxicology
Date received: 2003-10-21
Decision date: 2003-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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