Cleared Traditional

K962523 - N LATEX CRP MONO REAGENT

K962523 is an FDA 510(k) clearance for N LATEX CRP MONO REAGENT, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K962523 · Behring Diagnostics, Inc. · Immunology device
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Jul 1996
Decision
41d
Days
Class 2
Risk

K962523 is an FDA 510(k) clearance for the N LATEX CRP MONO REAGENT. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on July 10, 1996 after a review of 41 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K962523

510(k) Number K962523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1996
Decision Date July 10, 1996
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 105d · This submission: 41d
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 K962523.
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K963061 · Beckman Instruments, Inc. · Nov 1996
QUALITROL CRP CONTROL SET
K961829 · Consolidated Technologies, Inc. · Aug 1996
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
K962373 · 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
WAKO AUTOKIT CRP NEW
K955156 · Wako Chemicals USA, Inc. · Feb 1996