Cleared Traditional

K110035 - INDIKO

K110035 is an FDA 510(k) clearance for INDIKO, manufactured by Thermofisher Scientific OY. The device is a Class 1 Chemistry device with product code JJE cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K110035 · Thermofisher Scientific OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
174d
Days
Class 1
Risk

K110035 is an FDA 510(k) clearance for the INDIKO. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on June 28, 2011 after a review of 174 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 Thermofisher Scientific OY devices

FDA 510(k) Submission Details - K110035

510(k) Number K110035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2011
Decision Date June 28, 2011
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 88d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 157
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