Cleared Traditional

K860629 - BIOGRAM APO A1/B (FDA 510(k) Clearance)

Class I Immunology device.

K860629 · Bio-Rad · Immunology device
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Mar 1986
Decision
37d
Days
Class 1
Risk

K860629 is an FDA 510(k) clearance for the BIOGRAM APO A1/B. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Bio-Rad (Richmond, US). The FDA issued a Cleared decision on March 28, 1986 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - 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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Submission Details

510(k) Number K860629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date March 28, 1986
Days to Decision 37 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 104d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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.