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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrolyte controls (assayed and unassayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJR
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
I-STAT
  SUBSTANTIALLY EQUIVALENT 1
  1.  K934641  I-STAT CONTROL LEVELS 1,2,3

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