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510(k) K810253

SODIUM & POTASSIUM TEST KIT by Mallinckrodt Critical Care — Product Code JGM

K810253 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "SODIUM & POTASSIUM TEST KIT". The FDA issued a decision of Substantially Equivalent on February 10, 1981. The device falls under product code JGM (Flame Photometry, Potassium), a Class II device regulated under 21 CFR 862.1600. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1981
Date Received
January 30, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Potassium
Device Class
Class II
Regulation Number
862.1600
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 JGM

  • K895718 — LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER (October 19, 1989)
  • K862300 — AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT (July 29, 1986)
  • K831300 — MSI-NAK-50 TEST KIT (July 18, 1983)
  • K771068 — TRIGLYCERIDE KIT (July 12, 1977)

FDA data resources