Cleared Traditional

K964687 - N LATEX CRP MONO REAGENT

K964687 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 DCH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K964687 · Behring Diagnostics, Inc. · Immunology device
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Dec 1996
Decision
90d
Days
Class 2
Risk

K964687 is an FDA 510(k) clearance for the N LATEX CRP MONO REAGENT. Classified as System, Test, C-reactive Protein, Rhodamine (product code DCH), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 90 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K964687

510(k) Number K964687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1996
Decision Date December 16, 1996
Days to Decision 90 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
15d faster than avg
Panel avg: 105d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCH Device Classification - Class 2, Special Controls

Product Code DCH System, Test, C-reactive Protein, Rhodamine
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.