Cleared Special

OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

K981743 · Olympus America, Inc. · Chemistry
Jun 1998
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K981743 is an FDA 510(k) clearance for the OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER, a Acid Phosphatase, Naphthyl Phosphate (Class II — Special Controls, product code CKB), submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on June 9, 1998, 22 days after receiving the submission on May 18, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K981743 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1998
Decision Date June 09, 1998
Days to Decision 22 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CKB — Acid Phosphatase, Naphthyl Phosphate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1020

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