Cleared Traditional

K850160 - FISHER DIAGNOSTICS LATEST-CRP TEST KIT

K850160 is the FDA 510(k) clearance for FISHER DIAGNOSTICS LATEST-CRP TEST KIT by Fisher Diagnostics. It is a Class 2 Immunology device (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.

View all Fisher Diagnostics devices

Submission Details

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
10d faster than avg
Panel avg: 104d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 82
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K850160.
DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR
K860549 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1986
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
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI
K831958 · Kent Laboratories, Inc. · Jul 1983
PRISMA C-REACTIVE PROTEIN CONTROLS
K823415 · Syva Co. · Dec 1982
PRISMA C-REACTIVE PROTEIN ASSAY
K823416 · Syva Co. · Dec 1982