Cleared Traditional

EASY ANALYZER & EASY-TEST REAGENT

K853699 · Diagnostic Systems · Chemistry
Sep 1985
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K853699 is an FDA 510(k) clearance for the EASY ANALYZER & EASY-TEST REAGENT, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on September 25, 1985, 21 days after receiving the submission on September 4, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K853699 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1985
Decision Date September 25, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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