Cleared Traditional

K882873 - FIELDTEX HEMATOXYLIN

K882873 is an FDA 510(k) clearance for FIELDTEX HEMATOXYLIN, manufactured by Anatech, Ltd.. The device is a Class 1 Pathology device with product code KQC cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K882873 · Anatech, Ltd. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
17d
Days
Class 1
Risk

K882873 is an FDA 510(k) clearance for the FIELDTEX HEMATOXYLIN. Classified as Stains, Hematology (product code KQC), Class I - General Controls.

Submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology device 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 - K882873

510(k) Number K882873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1988
Decision Date July 28, 1988
Days to Decision 17 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 78d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

KQC Device Classification - Class 1, General Controls

Product Code KQC Stains, Hematology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - KQC Stains, Hematology

All 7
Devices cleared under the same product code (KQC) and FDA review panel - the closest regulatory comparables to K882873.
GENERAL DIAGNOSTICS COAG-A-MATE XC
K852843 · Warner-Lambert Co. · Aug 1985
RETIC-SET
K843619 · R&D Systems, Inc. · Oct 1984
RETIC-SET
K841848 · R&D Systems, Inc. · May 1984
PONCEAU S STAIN SET
K792550 · Electrophoresis Corp. of America · Jan 1980
VOLU-SOL NMB RETICULOCYTE STAIN
K792496 · Volu Sol Medical Industries · Dec 1979
HEMASTAIN FIXATIVE
K760485 · Geometric Data, Div. Smithkline Corp. · Aug 1976