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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Dimension EXL 200 integrated chemistry system; Dimension EXL with LM and STM Ready; Dimension EXL with LM integrated chemistry system
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: K130276
Owner/Operator: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner/Operator Number: 9096044
Establishment Operations: Manufacturer
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