Cleared Traditional

DSL ACTIVE ALDOSTERONE RIA (DSL 8600)

K943397 · Diagnostic Systems Laboratories, Inc. · Chemistry
Feb 1995
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K943397 is an FDA 510(k) clearance for the DSL ACTIVE ALDOSTERONE RIA (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 February 13, 1995, 214 days after receiving the submission on July 14, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1045.

Submission Details

510(k) Number K943397 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1994
Decision Date February 13, 1995
Days to Decision 214 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

Similar Devices — CJM Radioimmunoassay, Aldosterone

All 11
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
K142994 · Immunodiagnostic Systems , Ltd. · Apr 2015
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS
K130321 · Diasorin · Apr 2013
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K050784 · Nichols Institute Diagnostics · Jun 2005
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K032188 · Nichols Institute Diagnostics · Jul 2003
DSL ACTIVE ALDOSTERONE (DSL 8600)
K921205 · Diagnostic Systems Laboratories, Inc. · Jul 1992
RSL (125I) ALDOSTERONE KIT
K862204 · Radioassay Systems Laboratories, Inc. · Sep 1986