Cleared Traditional

K833505 - IL MODEL 840 MICROPROCESSOR LOADER

K833505 is the FDA 510(k) clearance for IL MODEL 840 MICROPROCESSOR LOADER by Instrumentation Laboratory CO. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K833505 · Instrumentation Laboratory CO · Chemistry device
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Jan 1984
Decision
92d
Days
Class 1
Risk

K833505 is an FDA 510(k) clearance for the IL MODEL 840 MICROPROCESSOR LOADER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K833505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1983
Decision Date January 11, 1984
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
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 43
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K833505.
SYVA IQ 190 DIGITAL PIPETTER DILUTER
K842390 · Syva Co. · Jul 1984
BEHRING ELISA PROCESSOR M
K841043 · Behring Diagnostics, Inc. · Jul 1984
MICROLAB M DILUTER/DISPENSER
K833959 · Syva Co. · Jan 1984
ACCU-PREP PROGRAMMABLE AUTO-DILUTER
K832809 · Beckman Instruments, Inc. · Oct 1983
PRO QUANTUM
K831249 · Abbott Laboratories · Jul 1983
QST TM SAMPLE PROCESSOR
K831273 · Syva Co. · Jun 1983