Cleared Traditional

K841465 - GENERAL DIAGNOSTICS PLATELET ANTIBODY

K841465 is an FDA 510(k) clearance for GENERAL DIAGNOSTICS PLATELET ANTIBODY, manufactured by General Diagnostics. The device is a Class 2 Immunology device with product code LLG cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K841465 · General Diagnostics · Immunology device
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Jul 1984
Decision
84d
Days
Class 2
Risk

K841465 is an FDA 510(k) clearance for the GENERAL DIAGNOSTICS PLATELET ANTIBODY. Classified as Kit, Igg, Platelet Associated (product code LLG), Class II - Special Controls.

Submitted by General Diagnostics (Walker, US). The FDA issued a Cleared decision on July 2, 1984 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.5425 - 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.

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FDA 510(k) Submission Details - K841465

510(k) Number K841465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1984
Decision Date July 02, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 105d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLG Device Classification - Class 2, Special Controls

Product Code LLG Kit, Igg, Platelet Associated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.