Cleared Traditional

K882362 - STAT FIX MICROWAVE IRRADIATION MEDIUM

K882362 is the FDA 510(k) clearance for STAT FIX MICROWAVE IRRADIATION MEDIUM by Stat Path. It is a Class 2 Pathology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K882362 · Stat Path · Pathology device
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Jun 1988
Decision
15d
Days
Class 2
Risk

K882362 is an FDA 510(k) clearance for the STAT FIX MICROWAVE IRRADIATION MEDIUM. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Stat Path (Riderwood, US). The FDA issued a Cleared decision on June 22, 1988 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.3870 - 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.

View all Stat Path devices

Submission Details

510(k) Number K882362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1988
Decision Date June 22, 1988
Days to Decision 15 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 77d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K882362.
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
K882313 · Syva Co. · Aug 1988
EMIT HVA CANNABINOID 100 NG ASSAY
K882819 · Syva Co. · Aug 1988
ABUSCREEN(R) ONTRAK(TM) FOR THC
K881814 · Roche Diagnostic Systems, Inc. · Jul 1988
REVISED LABELING FOR ADX CANNABINOIDS
K880015 · Abbott Laboratories · Mar 1988
ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH
K875252 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1988
TDXR DELTA-9-CANNABINOIDS
K874646 · Abbott Laboratories · Dec 1987