Cleared Traditional

I NETILMICIN RIA KIT (K790514) - FDA 510(k) Clearance

Class I Toxicology device.

K790514 · Diagnostic Products Corp. · Toxicology device
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May 1979
Decision
49d
Days
Class 1
Risk

K790514 is an FDA 510(k) clearance for the I NETILMICIN RIA KIT. Classified as Device, Media Dispensing/stacking (product code JTB), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.2440 - the FDA toxicology 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K790514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1979
Decision Date May 03, 1979
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 87d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTB Device, Media Dispensing/stacking
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2440
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.