Cleared Traditional

K882362 - STAT FIX MICROWAVE IRRADIATION MEDIUM (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 149
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