ADVIA IMS LITHIUM ASSAY— 510(k) K050374

Clearance details

Applicant

Bayer Healthcare, LLC

Product code

Code NDW

Device class

Class 2

Regulation

21 CFR 862.3560

Advisory panel

Clinical Toxicology

Date received

2005-02-14

Decision date

2005-06-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tarrytown, NY, US

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• Z-0104-2023 — Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assayClass II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20220919
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• Z-0589-2017 — Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20161007
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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050374.