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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Atellica CH Dilution Cuvette Segment; Atellica CH Reaction Cuvette Segment; Atellica IM Thyroid Stimulating Hormone (TSH) assay; Atellica Sampler Handler - SH Additional; Atellica Sampler Handler - SH Prime; Atellica Tube Top Sample Cup
Classification Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Product Code: JJE
Device Class: 1
Regulation Number: 862.2160
Medical Specialty: Clinical Chemistry
Registered Establishment Name: Siemens Healthcare Diagnostics Inc.
Registered Establishment Number: 2247117
Premarket Submission Number: K161954
Owner/Operator: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner/Operator Number: 9096044
Establishment Operations: Manufacturer
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