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510(k) K800868

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

K800868 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "FERRO-QUANT TM FE 59 TEST KIT". The FDA issued a decision of Substantially Equivalent on April 29, 1980. The device falls under product code JQG (Radiometric, Fe59, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.

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

Other clearances by Mallinckrodt Critical Care

  • K880343 — BURNEY GALLBLADDER CATHETER KIT (May 1, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE (January 29, 1988)
  • K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (January 6, 1988)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (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)

FDA data resources