Cleared Traditional

K896117 - MODIFIED MODEL 535(TM) LUMINOMETER

K896117 is the FDA 510(k) clearance for MODIFIED MODEL 535(TM) LUMINOMETER by Los Alamos Diagnostics. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K896117 · Los Alamos Diagnostics · Chemistry device
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Nov 1989
Decision
41d
Days
Class 1
Risk

K896117 is an FDA 510(k) clearance for the MODIFIED MODEL 535(TM) LUMINOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Los Alamos Diagnostics (Los Alamos, US). The FDA issued a Cleared decision on November 30, 1989 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Los Alamos Diagnostics devices

Submission Details

510(k) Number K896117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1989
Decision Date November 30, 1989
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 135
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K896117.
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COBAS READY
K896007 · Roche Diagnostic Systems, Inc. · Dec 1989
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MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER
K895313 · Dynatech Laboratories, Inc. · Oct 1989
DYNATECH MR 5000, CATALOG #011-976-0600
K894687 · Dynatech Laboratories, Inc. · Aug 1989