Cleared Traditional

ACS ESTADIOL-6 II

K970386 · Chiron Diagnostics Corp. · Chemistry
Jun 1997
Decision
121d
Days
Class 1
Risk

About This 510(k) Submission

K970386 is an FDA 510(k) clearance for the ACS ESTADIOL-6 II, a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP), submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on June 4, 1997, 121 days after receiving the submission on February 3, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1260.

Submission Details

510(k) Number K970386 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1997
Decision Date June 04, 1997
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CHP — Radioimmunoassay, Estradiol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1260

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