Cleared Traditional

CORTISOL LIA

K010790 · Kmi Diagnostics, Inc. · Chemistry
Jan 2002
Decision
320d
Days
Class 2
Risk

About This 510(k) Submission

K010790 is an FDA 510(k) clearance for the CORTISOL LIA, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Kmi Diagnostics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 29, 2002, 320 days after receiving the submission on March 15, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K010790 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2001
Decision Date January 29, 2002
Days to Decision 320 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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