Cleared Traditional

K993957 - DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR

K993957 is an FDA 510(k) clearance for DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROG..., manufactured by Dako Corp.. The device is a Class 2 Pathology device with product code MYA cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K993957 · Dako Corp. · Pathology device
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Optimized for regulatory review, auditing and printing
Mar 2000
Decision
102d
Days
Class 2
Risk

K993957 is an FDA 510(k) clearance for the DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR. Classified as Immunohistochemistry Antibody Assay, Estrogen Receptor (product code MYA), Class II - Special Controls.

Submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on March 3, 2000 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dako Corp. devices

FDA 510(k) Submission Details - K993957

510(k) Number K993957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1999
Decision Date March 03, 2000
Days to Decision 102 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 77d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYA Device Classification - Class 2, Special Controls

Product Code MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
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 Pathology devices follow this clearance model.

Regulatory Peers - MYA Immunohistochemistry Antibody Assay, Estrogen Receptor

Devices cleared under the same product code (MYA) and FDA review panel - the closest regulatory comparables to K993957.
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K122556 · Leica Biosystems Newcastle, Ltd. · May 2014
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
K120663 · Dako North America, Inc. · Feb 2013
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · Ventana Medical Systems, Inc. · Dec 2012
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
K984567 · Ventana, Inc. · Aug 1999