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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 2San Urinary Tract Infection Test
Classification Name: TEST, URINE LEUKOCYTE
Product Code: LJX
Device Class: 1
Regulation Number: 864.7675
Medical Specialty: Hematology
Registered Establishment Name: 2SAN LLC
Registered Establishment Number: 3025041446
Premarket Submission Number: K100024
Owner/Operator: 2San LLC
Owner/Operator Number: 10088220
Establishment Operations: Complaint File Establishment
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