Cleared Traditional

K943205 - HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)

K943205 is an FDA 510(k) clearance for HUMAN IGG SUBCLASSES RID COMBI KIT (MOD..., manufactured by Research Diagnostics, Inc.. The device is a Class 1 Immunology device with product code DAS cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K943205 · Research Diagnostics, Inc. · Immunology device
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Sep 1994
Decision
64d
Days
Class 1
Risk

K943205 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION). Classified as Igg (fc Fragment Specific), Antigen, Antiserum, Control (product code DAS), Class I - General Controls.

Submitted by Research Diagnostics, Inc. (Flanders, US). The FDA issued a Cleared decision on September 7, 1994 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5530 - 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 Research Diagnostics, Inc. devices

FDA 510(k) Submission Details - K943205

510(k) Number K943205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date September 07, 1994
Days to Decision 64 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 105d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

DAS Device Classification - Class 1, General Controls

Product Code DAS Igg (fc Fragment Specific), Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5530
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 - DAS Igg (fc Fragment Specific), Antigen, Antiserum, Control

Devices cleared under the same product code (DAS) and FDA review panel - the closest regulatory comparables to K943205.
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