Cleared Traditional

K893419 - COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)

K893419 is an FDA 510(k) clearance for COULTER CLONE GAM-FITC POLY ANTI (IGG &..., manufactured by Coulter Immunology. The device is a Class 2 Microbiology device with product code DEW cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K893419 · Coulter Immunology · Microbiology device
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Aug 1989
Decision
93d
Days
Class 2
Risk

K893419 is an FDA 510(k) clearance for the COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM). Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5510 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Coulter Immunology devices

FDA 510(k) Submission Details - K893419

510(k) Number K893419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date August 03, 1989
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEW Device Classification - Class 2, Special Controls

Product Code DEW Igg, 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 Microbiology devices follow this clearance model.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 58
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K893419.
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K882083 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1988