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510(k) K832552

SODIUM TEST KIT by Mallinckrodt Critical Care — Product Code CEI

K832552 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "SODIUM TEST KIT". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code CEI (Uranyl Acetate/Zinc Acetate, Sodium), a Class II device regulated under 21 CFR 862.1665. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
August 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uranyl Acetate/Zinc Acetate, Sodium
Device Class
Class II
Regulation Number
862.1665
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 CEI

  • K043268 — SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 (February 15, 2005)
  • K914039 — SODIUM REAGENT SET (October 31, 1991)
  • K902572 — SODIUM REAGENT SET (July 10, 1990)

FDA data resources