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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device controls for blood-gases, (assayed and unassayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJS
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 9
  1.  K002120  LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
  2.  K002535  LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MO ...
  3.  K002536  LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODE ...
  4.  K002865  LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577 ...
  5.  K002866  LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL ...
  6.  K003239  LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 ...
  7.  K003242  LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), ...
  8.  K022525  LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADI ...
  9.  K022529  LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL S ...
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 3

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