Cleared Traditional

IMMULITE? 2000 Cortisol

K202826 · Siemens Healthcare Diagnostics Products, Ltd. · Toxicology
Jan 2021
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K202826 is an FDA 510(k) clearance for the IMMULITE? 2000 Cortisol, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Siemens Healthcare Diagnostics Products, Ltd. (Caerarfon, GB). The FDA issued a Cleared decision on January 15, 2021, 113 days after receiving the submission on September 24, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K202826 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2020
Decision Date January 15, 2021
Days to Decision 113 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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