Cleared Traditional

IMAGEN (K943557) - FDA 510(k) Clearance

Class I Microbiology device.

K943557 · Dako Diagnostics , Ltd. · Microbiology device
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Jan 1995
Decision
171d
Days
Class 1
Risk

K943557 is an FDA 510(k) clearance for the IMAGEN. Classified as Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 (product code GQS), Class I - General Controls.

Submitted by Dako Diagnostics , Ltd. (Cambridgeshire, GB). The FDA issued a Cleared decision on January 9, 1995 after a review of 171 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3400 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dako Diagnostics , Ltd. devices

Submission Details

510(k) Number K943557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date January 09, 1995
Days to Decision 171 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 102d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GQS Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3400
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.