Cleared Traditional

K896918 - MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DA...

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

K896918 · Dako Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 Hematology devices follow this clearance model.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 43
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
DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)
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