POTASSIUM TEST KIT— 510(k) K832553

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K832553 for POTASSIUM TEST KIT, Substantially Equivalent on 1983-09-20. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code CEJ
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1983-08-01
Decision date: 1983-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code CEJ

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K904033 — REFLOTRON POTASSIUM TEST TABS1990-11-06
K902574 — POTASSIUM REAGENT SET1990-07-10
K883585 — TECHNICON ASSIST POTASSIUM1988-11-29

More clearances from Mallinckrodt Critical Care

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K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE1988-01-29
K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR1988-01-06
K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)1987-11-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.