Cleared Traditional

K924726 - DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924726 · Dako Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
630d
Days
Class 2
Risk

K924726 is an FDA 510(k) clearance for the DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 630 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Dako Corp. devices

Submission Details

510(k) Number K924726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1992
Decision Date June 13, 1994
Days to Decision 630 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
526d slower than avg
Panel avg: 104d · This submission: 630d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEH Lambda, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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.