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U.S. Department of Health and Human Services

Product Classification

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Device strip, dialysate, ph, bicarbonate, glucose, acid, indicator
Regulation Description Hemodialysis system and accessories.
Definition Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNTZ
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type 510(k)
Regulation Number 876.5820
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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