QUALICHECK TM— 510(k) K771444

Substantially Equivalent

The London Co.

FDA 510(k) clearance K771444 for QUALICHECK TM, Substantially Equivalent on 1977-08-16. Applicant: The London Co.. Device class: 1.

Clearance details

Applicant: The London Co.
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1977-08-01
Decision date: 1977-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJS

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K130415 — HIGH METABOLITE QUALICHECK2013-03-26
K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 32013-03-15
K033063 — MISSION CONTROLS2003-12-12

More clearances from The London Co.

K802846 — TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.1980-12-17
K801848 — ICA1 IONIZED CALCIUM ANALYZER1980-10-31
K800224 — RADIOMETER ACID BASE LABORATORY-ABL-31980-02-22
K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-21978-07-27
K771263 — RADIOMHTER OSM-2 HEMOXIMETER1977-08-03

Recalls naming K771444

K-number listed on FDA's recall record

Z-0608-2013 — Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.Class III·Terminated·Radiometer America Inc·20060606

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K771444.

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