Cleared Traditional

K896918 - MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT

K896918 is an FDA 510(k) clearance for MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DA..., manufactured by Dako Corp.. The device is a Class 2 Hematology device with product code DEH cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K896918 · Dako Corp. · Hematology device
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Aug 1990
Decision
259d
Days
Class 2
Risk

K896918 is an FDA 510(k) clearance for the MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT. 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 August 27, 1990 after a review of 259 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.5550 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dako Corp. devices

FDA 510(k) Submission Details - K896918

510(k) Number K896918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1989
Decision Date August 27, 1990
Days to Decision 259 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 113d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEH Device Classification - Class 2, Special Controls

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 Hematology devices follow this clearance model.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 45
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K896918.
DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI
K924726 · Dako Corp. · Jun 1994
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K932136 · Dako Corp. · Jun 1994
PSA ANTIBODY KIT
K932326 · Ventana Medical Systems, Inc. · Aug 1993
BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902485 · Beckman Instruments, Inc. · Jun 1990
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
K875165 · Kallestad Diag, A Div. of Erbamont, Inc. · Jan 1988
QUANTIMETRIC PLUS LAMBDA REAGENT KIT
K855007 · Kallestad Laboratories, Inc. · Feb 1986