Cleared Traditional

IDS Cortisol

K202136 · Immunodiagnostic Systems , Ltd. · Chemistry
Apr 2021
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K202136 is an FDA 510(k) clearance for the IDS Cortisol, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Immunodiagnostic Systems , Ltd. (Boldon, GB). The FDA issued a Cleared decision on April 13, 2021, 256 days after receiving the submission on July 31, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K202136 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2020
Decision Date April 13, 2021
Days to Decision 256 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGR — Radioimmunoassay, Cortisol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1205

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