Cleared Traditional

K843614 - CORNING IMMUNOFIXATION SYS

K843614 is an FDA 510(k) clearance for CORNING IMMUNOFIXATION SYS, manufactured by Corning Medical & Scientific. The device is a Class 2 Chemistry device with 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.

FDA 510(k) Submission Details - K843614

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
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZP Device Classification - Class 2, Special Controls

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 53
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K843614.
GILFORD IMMUNOGLOBULIN A REAGENT
K853467 · Gilford · Sep 1985
RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM
K851284 · Cooper Biomedical, Inc. · Jun 1985
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A
K850582 · Applications Lab · Mar 1985
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
FITC GOAT ANTI-HUMAN IGA A CHAIN
K832263 · Gelco Diagnostics, Inc. · Oct 1983
K843614 · CORNING IMMUNOFIXATION SYS
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