Cleared Traditional

K935047 - AUTO DELFIA (FDA 510(k) Clearance)

Class I Chemistry device.

K935047 · Wallac OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
214d
Days
Class 1
Risk

K935047 is an FDA 510(k) clearance for the AUTO DELFIA. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on May 23, 1994 after a review of 214 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - 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 Wallac OY devices

Submission Details

510(k) Number K935047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1993
Decision Date May 23, 1994
Days to Decision 214 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
126d slower than avg
Panel avg: 88d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
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.