Cleared Traditional

K832648 - ACCLAIM

K832648 is the FDA 510(k) clearance for ACCLAIM by Electro-Nucleonics Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K832648 · Electro-Nucleonics Laboratories, Inc. · Chemistry device
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Sep 1983
Decision
46d
Days
Class 1
Risk

K832648 is an FDA 510(k) clearance for the ACCLAIM. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Electro-Nucleonics Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 Electro-Nucleonics Laboratories, Inc. devices

Submission Details

510(k) Number K832648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1983
Decision Date September 20, 1983
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 141
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