Cleared Traditional

Randox Calcium (Ca)

K182042 · Randox Laboratories, Ltd. · Chemistry
Oct 2018
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K182042 is an FDA 510(k) clearance for the Randox Calcium (Ca), a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on October 23, 2018, 85 days after receiving the submission on July 30, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K182042 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2018
Decision Date October 23, 2018
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJY — Azo Dye, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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