Cleared Traditional

K832648 - ACCLAIM

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

K832648 · Electro-Nucleonics Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K832648

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
43d faster than avg
Panel avg: 89d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

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 207
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K832648.
EPOS CHEMISTRY ANALYZER 5060 & 6410
K833448 · Emd Chemicals, Inc. · Dec 1983
IMPACT 400 #1447X2
K833067 · Gilford · Dec 1983
SPIRIT CHEMISTRY SYSTEM
K833116 · Baker Instructions Corp. · Nov 1983
TUBING KIT 446
K832584 · Shaban Mfg. Co. · Sep 1983
THERMOMIXER S213-PHOTOANALYZER S263
K831649 · Texas Intl. Laboratories, Inc. · Aug 1983
AUTO CAROUSE/WASH SOLUTION CONCENTRATE
K831518 · Syva Co. · Jun 1983
K832648 · ACCLAIM
Download PDF Electro-Nucleonics La…