Counter, Differential Cell

Product Code: GKZ

Hematology In Vitro And Other Medical Laser Products

Applicable Standards: Laser Products. [1040.10]

Code of Federal Regulations: 864.5220


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as GKZ

2320Counter, Differential CellAutomated Differential Cell Counter.

Total Product Life Cycle (TPLC) Devices

2320Counter, Differential CellAutomated Differential Cell Counter.

FDA Consensus Standards

Counter, Differential Cell [37753]21 CFR §864.5220 🔎
Counter, Differential Cell [21789]21 CFR §864.5220 🔎
Counter, Differential Cell [31790]21 CFR §864.5220 🔎
Counter, Differential Cell [21700]21 CFR §864.5220 🔎
Counter, Differential Cell [26069]21 CFR §864.5220 🔎
Counter, Differential Cell [29738]21 CFR §864.5220 🔎
Counter, Differential Cell [29734]21 CFR §864.5220 🔎

Pre-market Notifications for GKZ

BK210639Counter, Differential CellBeckman Coulter, Inc.
BK210559Counter, Differential CellSysmex America, Inc.
K200828Athelas HomeAthelas Inc.
K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter
K190898Sight OLOSight Diagnostics Ltd.
K190294CELL-DYN Emerald 22 AL SystemAbbott Laboratories
BK180283Automated Differential Cell CounterNanoentek, Inc.
K182886Cytomics FC 500 Series (MPL Or MCL) Flow CytometerBeckman Coulter
K182389Sysmex XN-L Automated Hematology AnalyzerSysmex America, Inc.
K181475 DxH 520 Hematology InstrumentBeckman Coulter
K181288Athelas OneAthelas Inc.
K180020HemoScreen Hematology AnalyzerPixCell Medical Technologies, Ltd.
K172604XW-100 Automated Hematology Analyzer For CLIA Waived UseSysmex America, Inc.
K171655Cobas M 511 Integrated Hematology AnalyzerRoche Diagnostics Hematology, Inc.
K170353ABX MICROS ES 60 OT And ABX MICROS ES 60 CTHORIBA ABX SAS

Global Unique Device Identification Database

00382906630285Counter, differential cell
00382906629951Counter, differential cell
00382906629678Counter, differential cell
00382906629654Counter, differential cell
00382906595348Counter, differential cell
00382906578808Counter, differential cell
00382906577702Counter, differential cell
00382906577696Counter, differential cell
00382906577665Counter, differential cell
00382906570819Counter, differential cell
00382906466037Counter, differential cell
00382906466020Counter, differential cell
00382906466013Counter, differential cell
00382906466006Counter, differential cell
00382906446114Counter, differential cell

Maude Adverse Events

CELL-DYN RUBY ANALYZERABBOTT DIAGNOSTICS DIVISION2020-03-30
ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLERSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-27
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-25
CELL-DYN SAPPHIRE ANALYZERABBOTT DIAGNOSTICS DIVISION2020-03-23
COULTER LH 750 HEMATOLOGY ANALYZERBECKMAN COULTER2020-03-23
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-23
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-23
BECKMAN COULTERBECKMAN COULTER2020-03-19
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-18
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-18
CELL-DYN SAPPHIRE ANALYZERABBOTT DIAGNOSTICS DIVISION2020-03-18
SYSMEX XN-10SYSMEX CORPORATION, I SQUARE2020-03-18
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-18
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-17
CELL-DYN EMERALD ANALYZERABBOTT DIAGNOSTICS DIVISION2020-03-16
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-12
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-11
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-11
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-11
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-03-11
UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMBECKMAN COULTER2020-03-05
ALINITY HQ PROCESSING MODULEABBOTT GMBH2020-03-05
CELL-DYN RUBY ANALYZERABBOTT DIAGNOSTICS DIVISION2020-03-05
ADVIA 560 HEMATOLOGY SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-05
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMBECKMAN COULTER2020-03-03
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-27
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-27
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-26
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-26
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-26
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-26
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-26
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-26
XN-10SYSMEX CORPORATION, I SQUARE2020-02-24
SYSMEX XE-5000SYSMEX CORPORATION2020-02-21
CELL-DYN SAPPHIRE ANALYZERABBOTT DIAGNOSTICS DIVISION2020-02-17
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMBECKMAN COULTER2020-02-13
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-13
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-13
FC 500 FLOW CYTOMETERBECKMAN COULTER2020-02-13
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