Cleared Traditional

K843779 - AUTOLOADER II

K843779 is an FDA 510(k) clearance for AUTOLOADER II, manufactured by Electro-Nucleonics Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K843779 · Electro-Nucleonics Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
100d
Days
Class 1
Risk

K843779 is an FDA 510(k) clearance for the AUTOLOADER II. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on January 3, 1985 after a review of 100 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.

View all Electro-Nucleonics Laboratories, Inc. devices

FDA 510(k) Submission Details - K843779

510(k) Number K843779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1984
Decision Date January 03, 1985
Days to Decision 100 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
12d slower than avg
Panel avg: 88d · This submission: 100d
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
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K843779.
POSID SAMPLER
K860508 · Organon Teknika Corp. · May 1986
DADE BLOOD GAS AMPUL INJECTOR
K852285 · American Dade · Jul 1985
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
K851403 · Ventrex Laboratories, Inc. · Jun 1985
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