Cleared Traditional

K993547 - BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY ...

K993547 is the FDA 510(k) clearance for BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY ... by Beckman Coulter, Inc.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K993547 · Beckman Coulter, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Feb 2000
Decision
105d
Days
Class 2
Risk

K993547 is an FDA 510(k) clearance for the BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULI.... Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 1, 2000 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K993547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1999
Decision Date February 01, 2000
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 104d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
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 Immunology devices follow this clearance model.

Regulatory Peers - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 51
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K993547.
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K981784 · The Binding Site, Ltd. · Dec 1999