Cleared Traditional

ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM (K932467) - FDA 510(k) Clearance

Class I Chemistry device.

K932467 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
165d
Days
Class 1
Risk

K932467 is an FDA 510(k) clearance for the ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 5, 1993 after a review of 165 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K932467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1993
Decision Date November 05, 1993
Days to Decision 165 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 88d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 257
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K932467.
IMX SELECT ANALYZER
K912368 · Abbott Laboratories · Sep 1991
ADX(TM) ANALYZER
K864566 · Abbott Laboratories · Feb 1987
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986
POSITIVE I.D. SYSTEM
K823266 · Abbott Laboratories · Dec 1982
QUANTUMATIC DUAL-WAVELENGTH SPECTRO
K812865 · Abbott Laboratories · Nov 1981
DUAL WAVELENGTH PHOTOMETER, 1177
K771909 · Abbott Laboratories · Dec 1977