Counter, Cell, Automated (particle Counter)

Product Code: GKL

Hematology In Vitro And Other Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10]

Code of Federal Regulations: 864.5200


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as GKL

2311Counter, Cell, Automated (particle Counter)Automated Cell Counter.

Total Product Life Cycle (TPLC) Devices

2311Counter, Cell, Automated (particle Counter)Automated Cell Counter.

FDA Consensus Standards

Counter, Cell, Automated (Particle Counter) [25011]21 CFR §864.5200 🔎
Counter, Cell, Automated (Particle Counter) [21789]21 CFR §864.5200 🔎
Counter, Cell, Automated (Particle Counter) [31790]21 CFR §864.5200 🔎

Pre-market Notifications for GKL

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.
K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIRIS DIAGNOSTICS
K071652HEMOCUE WBC SYSTEMHEMOCUE AB
K051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBAYER HEALTHCARE, LLC
K050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIRIS INTERNATIONAL, INC.
K032677SYSMEX POCH-100ISYSMEX AMERICA, INC.
K022331ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHODBAYER DIAGNOSTICS CORP.
K001683SYSMEX R-500SYSMEX CORPORATION OF AMERICA
K991070COULTER Z2 ANALYZERCOULTER CORP.
K981950SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500SYSMEX CORP.
K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERSYSMEX CORP.
K971998ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEMBAYER CORP.
K964375SYSMEX SE/RAM-1SYSMEX CORP.
K962988COULTER GEN-S SYSTEMCOULTER CORP.
K954607RETICULOCYTE METHODBAYER CORP.

Global Unique Device Identification Database

00382903492046COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00382903431731COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00382903431304COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00382903401673COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414473383COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414224329COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414224305COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414223032COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414222950COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414222943COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414222929COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414222912COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414222905COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414222899COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
00630414222882COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)

Maude Adverse Events

IQ 200 URINE ANALYZERBECKMAN COULTER IRELAND INC.2020-02-04
ADVIA AUTOSLIDE SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-01-09
ADVIA 120/2120/2120I SHEATH/RINSE 10 LSIEMENS HEALTHCARE DIAGNOSTICS INC.2018-11-28
SYSMEX POCH-100ISYSMEX CORPORATION2018-08-29
ADVIA 120/2120/2120I DIFF TIMEPACSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-06-30
ORCHARD SOFTWARE - HARVESTORCHARD SOFTWARE CORPORATION2016-04-01
COULTER? GEN-S? SYSTEMBECKMAN COULTER2013-12-06
ADVIA 2120 WITH DUAL ASPIRATESIEMENS HEALTHCARE DIAGNOSTICS INC.2013-09-21
ADVIA 120SIEMENS HEALTHCARE DIAGNOSTICS INC.2013-07-12
SYSMEX POCH-100I ANALYZERSYSMEX CORP2013-04-03
ADVIA 2120I WITH AUTOSAMPLERSIEMENS HEALTHCARE DIAGNOSTICS INC.2013-04-02
ADVIA 2120ISIEMENS HEALTHCARE DIAGNOSTICS INC.2013-03-21
ADVIA 120SIEMENS HEALTHCARE DIAGNOSTICS, INC.2013-03-04
ADVIA 2120ISIEMENS DIAGNOSTICS2013-02-08
COAT-A-COUNT FREE TESTOSTERONESIEMENS HEALTHCARE DIAGNOSTICS2013-02-01
ADVIA 120SIEMENS HEALTHCARE DIAGNOSTICS INC.2013-01-10
ADVIA 2120I WITH AUTOSAMPLERSIEMENS HEALTHCARE DIAGNOSTICS INC.2013-01-04
ADVIA 2120I WITH AUTOSAMPLERSIEMENS HEALTHCARE DIAGNOSTICS INC.2012-12-20
ADVIA 120SIEMENS HEALTHCARE DIAGNOSTICS INC.2012-11-15
ADVIA 2120SIEMENS HEALTHCARE DIAGNOSTICS, INC.2012-06-01
ADVIA 2120 WITH AUTOSAMPLERSIEMENS HEALTHCARE DIAGNOSTICS INC.2012-05-16
HARVEST ( LIS)ORCHARD SOFTWARE CORPORATION2012-05-04
HARVEST ( LIS)ORCHARD SOFTWARE CORPORATION2012-04-30
ADVIA 120SIEMENS HEALTHCARE DIAGNOSTICS2012-04-19
ADVIA 2120SIEMENS HEALTHCARE DIAGNOSTICS, INC.2012-03-08
ADVIA 2120ISIEMENS HEALTHCARE DIAGNOSTICS, INC.2012-03-02
ADVIA 2120I WITH AUTOSAMPLERSIEMENS HEALTHCARE DIAGNOSTICS INC.2012-02-28
ADVIA 120SIEMENS HEALTHCARE DIAGNOSTICS INC.2012-02-07
ADVIA 120SIEMENS HEALTHCARE DIAGNOSTICS, INC.2012-01-31
ADVIA 2120SIEMENS HEALTHCARE DIAGNOSTICS, INC.2012-01-30
ADVIA 2120SIEMENS HEALTHCARE DIAGNOSTICS2012-01-09
ADVIA 2120ISIEMENS HEALTHCARE DIAGNOSTICS INC.2011-12-29
ADVIA 2120SIEMENS HEALTHCARE DIAGNOSTICS, INC.2011-12-23
ADVIA 2120SIEMENS HEALTHCARE DIAGNOSTICS INC.2011-12-07
ADVIA 120SIEMENS HEALTHCARE DIAGNOSTICS INC.2011-12-07
COULTER GEN-S SYSTEMBECKMAN COULTER, INC.2011-12-01
ADVIA 2120ISIEMENS HEALTHCARE DIAGNOSTICS2011-11-11
ADVIA 2120ISIEMENS HEALTHCARE DIAGNOSTICS INC.2011-10-26
ADVIA 2120ISIEMENS HEALTHCARE DIAGNOSTICS2011-10-26
COULTER GEN-S SYSTEMBECKMAN COULTER, INC.2011-10-14
COULTER GEN-S SYSTEMBECKMAN COULTER, INC.2011-10-14
COULTER GEN-S SYSTEMBECKMAN COULTER, INC.2011-10-14
COULTER GEN-S SYSTEMBECKMAN COULTER, INC.2011-10-14
COULTER GEN-S SYSTEMBECKMAN COULTER, INC.2011-10-14
COULTER GEN-S SYSTEMBECKMAN COULTER, INC.2011-10-14
COULTER GEN-S SYSTEMBECKMAN COULTER, INC.2011-10-07
COULTER GEN-S SYSTEMBECKMAN COULTER, INC.2011-10-07
TRUCOLOR WRIGHT STAINBECKMAN COULTER, INC.2011-09-23
ADVIA 120SIEMENS HEALTHCARE DIAGNOSTICS INC.2011-08-26
ADVIA 2120SIEMENS HEALTHCARE DIAGNOSTICS INC.2011-08-24
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