Cleared Traditional

DSL ACTIVE ALDOSTERONE (DSL 8600)

K921205 · Diagnostic Systems Laboratories, Inc. · Chemistry
Jul 1992
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K921205 is an FDA 510(k) clearance for the DSL ACTIVE ALDOSTERONE (DSL 8600), a Radioimmunoassay, Aldosterone (Class II — Special Controls, product code CJM), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on July 10, 1992, 120 days after receiving the submission on March 12, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1045.

Submission Details

510(k) Number K921205 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1992
Decision Date July 10, 1992
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CJM — Radioimmunoassay, Aldosterone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1045

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