Cleared Traditional

K973954 - IMAGEN RESPIRATORY SCREEN

K973954 is an FDA 510(k) clearance for IMAGEN RESPIRATORY SCREEN, manufactured by Dako Diagnostics , Ltd.. The device is a Class 1 Microbiology device with product code GNW cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K973954 · Dako Diagnostics , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
74d
Days
Class 1
Risk

K973954 is an FDA 510(k) clearance for the IMAGEN RESPIRATORY SCREEN. Classified as Antisera, Cf, Influenza Virus A, B, C (product code GNW), Class I - General Controls.

Submitted by Dako Diagnostics , Ltd. (Cambridgeshire, GB). The FDA issued a Cleared decision on December 22, 1997 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - 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: 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 Dako Diagnostics , Ltd. devices

FDA 510(k) Submission Details - K973954

510(k) Number K973954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1997
Decision Date December 22, 1997
Days to Decision 74 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 102d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

GNW Device Classification - Class 1, General Controls

Product Code GNW Antisera, Cf, Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
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 - GNW Antisera, Cf, Influenza Virus A, B, C

All 11
Devices cleared under the same product code (GNW) and FDA review panel - the closest regulatory comparables to K973954.
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