Cleared Traditional

STAT FAX 2600 (K941394) - FDA 510(k) Clearance

Class I Chemistry device.

K941394 · Awareness Technology, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
73d
Days
Class 1
Risk

K941394 is an FDA 510(k) clearance for the STAT FAX 2600. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on June 3, 1994 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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

Submission Details

510(k) Number K941394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1994
Decision Date June 03, 1994
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 32
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K941394.
BD VIPER INSTRUMENT
K023955 · Becton, Dickinson & CO · Jun 2003
MASTERCAP AM 5.0/MASTERCAP RM 5.0
K970420 · Pharmacia, Inc. · Jun 1997
ROBOCAP
K952025 · Pharmacia, Inc. · Jul 1995
MAXSOFTWARE
K925547 · Diagnostic Products Corp. · Jan 1993
ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE
K923879 · Diagnostic Products Corp. · Dec 1992
MARK 5 ROBOTIC PIPETTOR
K912228 · Diagnostic Products Corp. · Jun 1991