Cleared Traditional

K843614 - CORNING IMMUNOFIXATION SYS

K843614 is the FDA 510(k) clearance for CORNING IMMUNOFIXATION SYS by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code CZP) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K843614 · Corning Medical & Scientific · Chemistry device
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Oct 1984
Decision
21d
Days
Class 2
Risk

K843614 is an FDA 510(k) clearance for the CORNING IMMUNOFIXATION SYS. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K843614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1984
Decision Date October 05, 1984
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZP Iga, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Chemistry devices follow this clearance model.

Regulatory Peers - CZP Iga, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K843614.
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046 · Abbott Laboratories · Aug 1986
DAKO ITA, IMMUNOGLOBULIN A (IGA)
K862183 · Dako Corp. · Aug 1986
QUANTIMETRIC PLUS IGA REAGENT KIT
K855009 · Kallestad Laboratories, Inc. · Feb 1986
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
K842468 · Miles Laboratories, Inc. · Aug 1984
AMER. HISTO-ID SYS PRIMARY IGA 2720-21
K842330 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
IMMUNOGLOBULIN CONTROL
K823566 · Syva Co. · Dec 1982