Cleared Traditional

K840938 - HIGH SPEED DISPENSER

K840938 is the FDA 510(k) clearance for HIGH SPEED DISPENSER by Micromedic Systems. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K840938 · Micromedic Systems · Chemistry device
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Apr 1984
Decision
45d
Days
Class 1
Risk

K840938 is an FDA 510(k) clearance for the HIGH SPEED DISPENSER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Micromedic Systems (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984 after a review of 45 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 Micromedic Systems devices

Submission Details

510(k) Number K840938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1984
Decision Date April 19, 1984
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
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 64
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K840938.
FIAX 420 DILUTOR
K843621 · Intl. Diagnostic Technology · Sep 1984
SYVA IQ 190 DIGITAL PIPETTER DILUTER
K842390 · Syva Co. · Jul 1984
BEHRING ELISA PROCESSOR M
K841043 · Behring Diagnostics, Inc. · Jul 1984
ACCUFLEX
K834590 · Micromedic Systems · Mar 1984
MICROLAB M DILUTER/DISPENSER
K833959 · Syva Co. · Jan 1984
IL MODEL 840 MICROPROCESSOR LOADER
K833505 · Instrumentation Laboratory CO · Jan 1984