Cleared Traditional

IMMUNODIFFUSION BAND INTENSIFYING FLUID (K812194) - FDA 510(k) Clearance

Class I Microbiology device.

K812194 · American Scientific Products · Microbiology device
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Aug 1981
Decision
28d
Days
Class 1
Risk

K812194 is an FDA 510(k) clearance for the IMMUNODIFFUSION BAND INTENSIFYING FLUID. Classified as Electrophoresis Instrumentation (product code JZS), Class I - General Controls.

Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.4500 - the FDA microbiology 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.

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Submission Details

510(k) Number K812194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1981
Decision Date August 31, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZS Electrophoresis Instrumentation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4500
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.