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510(k) K800868

FERRO-QUANT TM FE 59 TEST KIT by Mallinckrodt Critical Care — Product Code JQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1980
Date Received
April 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiometric, Fe59, Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type

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  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (November 6, 1987)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873833 — THERMOCOUPLE ADAPTER (November 3, 1987)
  • K873004 — GUIDING CATHETER (September 15, 1987)
  • K871204 — CUFFED TRACHEAL TUBE (MULTIPLE) (April 21, 1987)
  • K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (August 1, 1986)

Other clearances for product code JQG

  • K811954 — COMBO-FER IRON DIAGNOSTIC (July 27, 1981)
  • K800710 — FERRITIRON KIT CAT. #RP-1100 (May 14, 1980)
  • K790133 — SPINSEP-FE59 (March 2, 1979)
  • K780412 — TOTAL IRON BINDING CAPACITY (May 26, 1978)