Cleared Traditional

TRANSFERMETER (K863066) - FDA 510(k) Clearance

Class I Chemistry device.

K863066 · J. D. Assoc. · Chemistry device
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Dec 1986
Decision
114d
Days
Class 1
Risk

K863066 is an FDA 510(k) clearance for the TRANSFERMETER. Classified as Bathophenanthroline, Iron Binding Capacity (product code JQF), Class I - General Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 4, 1986 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1415 - 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 J. D. Assoc. devices

Submission Details

510(k) Number K863066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date December 04, 1986
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 88d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQF Bathophenanthroline, Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
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.