Randox Calcium (Ca)— 510(k) K182042

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K182042 for Randox Calcium (Ca), Substantially Equivalent on 2018-10-23. 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: 2018-07-30
Decision date: 2018-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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Recalls naming K182042

K-number listed on FDA's recall record

Z-0840-2019 — Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368Class 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 K182042.

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