Cleared Traditional

DSL 1900

K830816 · Diagnostic Systems · Chemistry
Apr 1983
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K830816 is an FDA 510(k) clearance for the DSL 1900, a Radioimmunoassay, Estriol (Class I — General Controls, product code CGI), submitted by Diagnostic Systems (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983, 28 days after receiving the submission on March 15, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1265.

Submission Details

510(k) Number K830816 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1983
Decision Date April 12, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGI — Radioimmunoassay, Estriol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1265

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