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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: ACTH Control Module; Albumin Control Module; IML 2000 Albumin; IML 2000 Insulin; IMMULITE 1000 System; IMMULITE 2000 Albumin; IMMULITE Albumin; IMMULITE Albumin Control Module; IMMULITE Albumin Sample Diluent; IMMULITE Insulin; IMMULITE/IMMULITE 1000 Albumin; IMMULITE/IMMULITE 1000 Chemiluminescent Substrate Module; IMMULITE/IMMULITE 1000 Systems Sample Cup Caps; IMMULITE/IMMULITE 1000 Systems Sample Cups; Insulin Control Module
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: K022603
Owner/Operator: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner/Operator Number: 9096044
Establishment Operations: Manufacturer; Specification Developer
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