Cleared Traditional

K974762 - STAT TRACKS

K974762 is an FDA 510(k) clearance for STAT TRACKS, manufactured by Awareness Technology, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K974762 · Awareness Technology, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
40d
Days
Class 1
Risk

K974762 is an FDA 510(k) clearance for the STAT TRACKS. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on January 28, 1998 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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: 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 Awareness Technology, Inc. devices

FDA 510(k) Submission Details - K974762

510(k) Number K974762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1997
Decision Date January 28, 1998
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 151
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