Cleared Traditional

K850160 - FISHER DIAGNOSTICS LATEST-CRP TEST KIT

K850160 is an FDA 510(k) clearance for FISHER DIAGNOSTICS LATEST-CRP TEST KIT, manufactured by Fisher Diagnostics. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K850160 · Fisher Diagnostics · Immunology device
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Apr 1985
Decision
94d
Days
Class 2
Risk

K850160 is an FDA 510(k) clearance for the FISHER DIAGNOSTICS LATEST-CRP TEST KIT. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Fisher Diagnostics (Orangeburg, US). The FDA issued a Cleared decision on April 19, 1985 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 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.

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FDA 510(k) Submission Details - K850160

510(k) Number K850160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1985
Decision Date April 19, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 105d · This submission: 94d
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 106
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K850160.
DU PONT C-REACTIVE PROTEIN (CRP) ASSAY
K860550 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1986
TDX C-REACTIVE PROTEIN
K854542 · Abbott Laboratories · Jan 1986
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
K851842 · Atlantic Antibodies · Jun 1985
FIAX CRP TEST KIT
K832054 · Intl. Diagnostic Technology · Aug 1983
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI
K831958 · Kent Laboratories, Inc. · Jul 1983
PRISMA C-REACTIVE PROTEIN CONTROLS
K823415 · Syva Co. · Dec 1982