Cleared Traditional

K961694 - IMPACT

K961694 is an FDA 510(k) clearance for IMPACT, manufactured by Matrix Technologies Corp.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K961694 · Matrix Technologies Corp. · Chemistry device
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Jun 1996
Decision
51d
Days
Class 1
Risk

K961694 is an FDA 510(k) clearance for the IMPACT. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Matrix Technologies Corp. (Lowell, US). The FDA issued a Cleared decision on June 21, 1996 after a review of 51 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 Matrix Technologies Corp. devices

FDA 510(k) Submission Details - K961694

510(k) Number K961694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1996
Decision Date June 21, 1996
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

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 83
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