CHOLESTEROL REAGENT— 510(k) K771313

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K771313 for CHOLESTEROL REAGENT, Substantially Equivalent on 1977-08-03. Applicant: Mallinckrodt Critical Care. Device class: 1.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code CGO
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1977-07-18
Decision date: 1977-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code CGO

K850938 — CHOLESTEROL1985-06-25
K811747 — KING DIAGNOSTICS CHOLESTEROL TEST1981-07-10
K810090 — CHOLESTEROL REAGENT1981-01-26
K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM1980-05-28
K781611 — CHOLESTEROL DET. IN SERUM1978-10-24

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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.