Cleared Traditional

FLAME PHOTOMETERS

K834226 · Dr. Bruno Lange GmbH · Chemistry
Jun 1984
Decision
199d
Days
Class 1
Risk

About This 510(k) Submission

K834226 is an FDA 510(k) clearance for the FLAME PHOTOMETERS, a Flame Emission Photometer For Clinical Use (Class I — General Controls, product code JJO), submitted by Dr. Bruno Lange GmbH (Walker, US). The FDA issued a Cleared decision on June 22, 1984, 199 days after receiving the submission on December 6, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2540.

Submission Details

510(k) Number K834226 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1983
Decision Date June 22, 1984
Days to Decision 199 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJO — Flame Emission Photometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2540