Cleared Traditional

K023992 - WIENER LAB COLINESTERASA AA

K023992 is an FDA 510(k) clearance for WIENER LAB COLINESTERASA AA, manufactured by Wiener Laboratories Saic. The device is a Class 1 Chemistry device with product code DIH cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K023992 · Wiener Laboratories Saic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
72d
Days
Class 1
Risk

K023992 is an FDA 510(k) clearance for the WIENER LAB COLINESTERASA AA. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on February 12, 2003 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3240 - 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 Wiener Laboratories Saic devices

FDA 510(k) Submission Details - K023992

510(k) Number K023992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2002
Decision Date February 12, 2003
Days to Decision 72 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
16d faster than avg
Panel avg: 88d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

DIH Device Classification - Class 1, General Controls

Product Code DIH Colorimetry, Cholinesterase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
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 - DIH Colorimetry, Cholinesterase

All 20
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K023992.
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
K103373 · Beckman Coulter, Inc. · Feb 2011
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · Roche Diagnostics Corp. · Jul 2006
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045 · Olympus America, Inc. · Feb 2003
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · Bayer Diagnostics Corp. · Jan 2002
ADVIA IMS
K001344 · Bayer Corp. · Jun 2000
IL TEST CHOLINESTERASE
K943367 · Instrumentation Laboratory CO · Feb 1996