Cleared Traditional

K952615 - WAKO AUTOKIT APO A1 (FDA 510(k) Clearance)

Class I Immunology device.

K952615 · Wako Chemicals USA, Inc. · Immunology device
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Sep 1995
Decision
94d
Days
Class 1
Risk

K952615 is an FDA 510(k) clearance for the WAKO AUTOKIT APO A1. Classified as Turbidimetric Method, Lipoproteins (product code JHN), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K952615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1995
Decision Date September 08, 1995
Days to Decision 94 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
10d faster than avg
Panel avg: 104d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHN Turbidimetric Method, Lipoproteins
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.