Cleared Traditional

EPOS CHEMISTRY ANALYZER 5060 & 6410

K833448 · Emd Chemicals, Inc. · Chemistry
Dec 1983
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K833448 is an FDA 510(k) clearance for the EPOS CHEMISTRY ANALYZER 5060 & 6410, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983, 78 days after receiving the submission on October 5, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K833448 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1983
Decision Date December 22, 1983
Days to Decision 78 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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