Cleared Traditional

K812194 - IMMUNODIFFUSION BAND INTENSIFYING FLUID

K812194 is the FDA 510(k) clearance for IMMUNODIFFUSION BAND INTENSIFYING FLUID by American Scientific Products. It is a Class 1 Microbiology device (product code JZS) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

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.

View all American Scientific Products devices

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.

Regulatory Peers - JZS Electrophoresis Instrumentation

Devices cleared under the same product code (JZS) and FDA review panel - the closest regulatory comparables to K812194.
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K770718 · Kallestad Laboratories, Inc. · Apr 1977
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K770719 · Kallestad Laboratories, Inc. · Apr 1977