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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: DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
Product Code: JMT
Device Class: 1
Regulation Number: 862.1510
Medical Specialty: Clinical Chemistry
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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