Cleared Traditional

K862148 - OLYMPUS AU 5000 FLAME PHOTOMETER MODULE
(FDA 510(k) Clearance)

K862148 · Olympus Corp. · Chemistry device

Sep 1986

Decision

117d

Days

Class 1

Risk

K862148 is an FDA 510(k) clearance for the OLYMPUS AU 5000 FLAME PHOTOMETER MODULE. This device is classified as a Flame Emission Photometer For Clinical Use (Class I - General Controls, product code JJO).

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on September 29, 1986, 117 days after receiving the submission on June 4, 1986.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2540.

Submission Details

510(k) Number	K862148 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 04, 1986
Decision Date	September 29, 1986
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—