Cleared Traditional

K960874 - COMPLEMENT CONTROL

K960874 is an FDA 510(k) clearance for COMPLEMENT CONTROL, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Immunology device with product code JJX cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K960874 · Wako Chemicals USA, Inc. · Immunology device
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Jun 1996
Decision
102d
Days
Class 1
Risk

K960874 is an FDA 510(k) clearance for the COMPLEMENT CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on June 14, 1996 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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

FDA 510(k) Submission Details - K960874

510(k) Number K960874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1996
Decision Date June 14, 1996
Days to Decision 102 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 105d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 444
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K960874.
OPUS B12 CONTROLS
K962694 · Behring Diagnostics, Inc. · Jul 1996
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
K962432 · Clinical Controls, Inc. · Jul 1996
ACS FRT4 IMMUNOASSAY
K961510 · Ciba Corning Diagnostics Corp. · Jun 1996
OPUS T3 CONTROLS
K961206 · Behring Diagnostics, Inc. · Apr 1996
ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS
K960378 · Actimed Laboratories, Inc. · Apr 1996
LXN FRUCTOSAMINE TEST
K955629 · Lxn Corp. · Mar 1996