Cleared Special

K983562 - MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD...

K983562 is the FDA 510(k) clearance for MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD... by Cdc Technologies, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Special 510(k) pathway after a 21-day FDA review.

K983562 · Cdc Technologies, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
21d
Days
Class 2
Risk

K983562 is an FDA 510(k) clearance for the MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Cdc Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on November 3, 1998 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cdc Technologies, Inc. devices

Submission Details

510(k) Number K983562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date November 03, 1998
Days to Decision 21 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K983562.
COULTER AC T DIFF 2 ANALYZER
K990352 · Coulter Corp. · Apr 1999
CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
K982167 · Coulter Corp. · Nov 1998
CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
K982166 · Coulter Corp. · Nov 1998
CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL
K982172 · Coulter Corp. · Sep 1998
BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K982802 · Bayer Corp. · Sep 1998
DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
K980635 · Dako Corp. · Jul 1998