Cleared Traditional

K770548 - IMMUNOPLATE III RADIO IMMUNODIFFUSION (FDA 510(k) Clearance)

Class I Immunology device.

K770548 · Hyland Therapeutic Div., Travenol Laboratories · Immunology device
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Apr 1977
Decision
25d
Days
Class 1
Risk

K770548 is an FDA 510(k) clearance for the IMMUNOPLATE III RADIO IMMUNODIFFUSION. Classified as Plates And Equipment, Radial Immunodiffusion (product code JZQ), Class I - General Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 15, 1977 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4800 - the FDA immunology 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 Hyland Therapeutic Div., Travenol Laboratories devices

Submission Details

510(k) Number K770548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1977
Decision Date April 15, 1977
Days to Decision 25 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 104d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZQ Plates And Equipment, Radial Immunodiffusion
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4800
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.