Cleared Traditional

K955156 - WAKO AUTOKIT CRP NEW

K955156 is an FDA 510(k) clearance for WAKO AUTOKIT CRP NEW, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K955156 · Wako Chemicals USA, Inc. · Immunology device
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Feb 1996
Decision
95d
Days
Class 2
Risk

K955156 is an FDA 510(k) clearance for the WAKO AUTOKIT CRP NEW. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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 - K955156

510(k) Number K955156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date February 16, 1996
Days to Decision 95 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
10d faster than avg
Panel avg: 105d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 105
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K955156.
N LATEX CRP MONO REAGENT
K962523 · Behring Diagnostics, Inc. · Jul 1996
CRP-LATEX SEIKEN XR REAGENT SYSTEM
K960702 · Globe Management Support, Inc. · Apr 1996
HEMAGEN CRP 150 KIT (EIA METHOD)
K960324 · Hemagen Diagnostics, Inc. · Mar 1996
C-REACTIVE PROTEIN LATEX KIT
K954447 · Randox Laboratories, Ltd. · Dec 1995
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
K953207 · The Binding Site, Ltd. · Aug 1995
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
K953197 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995