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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 1037632 Bilichek (Advanced); B800-500 BiliCal; 50 Pack
Classification Name: BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
Product Code: MQM
Device Class: 1
Regulation Number: 862.1113
Medical Specialty: Clinical Chemistry
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K010052
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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