Cleared Traditional

FLAME PHOTOMETERS (K834226) - FDA 510(k) Clearance

Class I Chemistry device.

K834226 · Dr. Bruno Lange GmbH · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
199d
Days
Class 1
Risk

K834226 is an FDA 510(k) clearance for the FLAME PHOTOMETERS. Classified as Flame Emission Photometer For Clinical Use (product code JJO), Class I - General Controls.

Submitted by Dr. Bruno Lange GmbH (Walker, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 199 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2540 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dr. Bruno Lange GmbH devices

Submission Details

510(k) Number K834226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1983
Decision Date June 22, 1984
Days to Decision 199 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 88d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJO Flame Emission Photometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.