Cleared Traditional

K843375 - ELVI 655 FLAME PHOTOMETER

K843375 is an FDA 510(k) clearance for ELVI 655 FLAME PHOTOMETER, manufactured by Logos Scientific, Inc.. The device is a Class 1 Chemistry device with product code JJO cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K843375 · Logos Scientific, Inc. · Chemistry device
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May 1985
Decision
265d
Days
Class 1
Risk

K843375 is an FDA 510(k) clearance for the ELVI 655 FLAME PHOTOMETER. Classified as Flame Emission Photometer For Clinical Use (product code JJO), Class I - General Controls.

Submitted by Logos Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 265 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.

FDA 510(k) Submission Details - K843375

510(k) Number K843375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date May 20, 1985
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 89d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

JJO Device Classification - Class 1, General Controls

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.

Regulatory Peers - JJO Flame Emission Photometer For Clinical Use

All 21
Devices cleared under the same product code (JJO) and FDA review panel - the closest regulatory comparables to K843375.
FINNIGAN MAT INCOS 50
K873603 · Finnigan Corp. · Sep 1987
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE
K862148 · Olympus Corp. · Sep 1986
LITHIUM REAGENT
K841847 · Reagent Laboratory, Inc. · Aug 1984
FLAME PHOTOMETERS
K834226 · Dr. Bruno Lange GmbH · Jun 1984
DAILY WASH SOLUTION 5
K841421 · Reagent Laboratory, Inc. · May 1984
VOLUME TEST DYE 6
K841422 · Reagent Laboratory, Inc. · May 1984
K843375 · ELVI 655 FLAME PHOTOMETER
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