RANDOX CALCIUM— 510(k) K974607

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K974607 for RANDOX CALCIUM, Substantially Equivalent on 1998-02-02. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CJY
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1997-12-10
Decision date: 1998-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

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Recalls naming K974607

K-number listed on FDA's recall record

Z-0839-2019 — Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904Class II·Terminated·Randox Laboratories Ltd.·20181204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974607.

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