URIC ACID TEST KIT— 510(k) K770564

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K770564 for URIC ACID TEST KIT, Substantially Equivalent on 1977-06-03. Applicant: Mallinckrodt Critical Care. Device class: 1.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code CDH
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1977-03-24
Decision date: 1977-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code CDH

K850933 — URIC ACID1985-06-25
K841067 — URIC ACID REAGENT SET1984-05-01
K821213 — URIC ACID REAGENT SET1982-07-13
K813076 — PHOSPHOTUNGSTATE REDUCTION, URIC ACID1981-11-16
K810088 — URIC ACID (TPTZ) COLORINMETRIC1981-01-28

More clearances from Mallinckrodt Critical Care

K880343 — BURNEY GALLBLADDER CATHETER KIT1989-05-01
K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR1988-02-02
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.