Atlas FDA

JII

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Atomic Absorption, Lithium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3560
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B (K082001)Diazyme Laboratories2008-12-05
DIAZYME LITHIUM ENZYMATIC ASSAY KIT (K033360)General Atomics2003-12-23
UROTEST GPH (K912244)In Wha Pharmaceutical Co., Ltd.1991-11-22

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Every clearance here is in the API, with alerts when new ones post.