Cleared Traditional

K932467 - ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM

K932467 is an FDA 510(k) clearance for ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM, manufactured by Instrumentation Laboratory CO. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 165-day FDA review.

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

FDA 510(k) Submission Details - K932467

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 88d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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 165
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K932467.
DUPONT ACA STAR
K941050 · Dupont Medical Products · Nov 1994
MRX MICROPLATE READER
K943701 · Dynatech Laboratories, Inc. · Oct 1994
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
K932778 · Boehringer Mannheim Corp. · Nov 1993
OMNI
K925625 · Bio-Tek Instruments, Inc. · Aug 1993
OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER
K925935 · Olympus Corp. · Apr 1993
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1
K925203 · Heraeus Kulzer, Inc. · Nov 1992