FDA.reportPublic FDA data

ClearLLab 10C

Primary DI
15099590694975
Brand
ClearLLab 10C
Company
BECKMAN COULTER IRELAND INC.
Model
B90003
Device description
ClearLLab Control Cells abnormal
Published
2019-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PWDFlow Cytometric Test System For Hematopoietic Neoplasms

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWDFlow Cytometric Test System For Hematopoietic NeoplasmsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183592000ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman Coulter2019-03-21PWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590694975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959069497515099590694975

GMDN Terms#

Term, Definition table
TermDefinition
Multiple CD cell marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985071975
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590695743iChemVELOCITYB793192026-04-27
15099590225889AQUIOS CL B301662016-09-23
15099590677466Navios EX10 Color 3 lasersB809102017-07-06
15099590682996Navios EX8 Color 2 lasersB809112017-07-06
15099590683009Navios EX6 Color 2 lasersB809122017-07-06
15099590683245Navios EXACQUISITION NEW USER SOFTWARE V2.0 WIN 7B91237 2017-07-06
15099590683252Navios EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7 B91238 2017-07-06
15099590683269Navios EXOFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7 B912392017-07-06
15099590683276Navios EXTETRA SOFTWARE V2.0 NEW USER B91240 2017-07-06
15099590671242DxH 500B40601B406012020-08-31
15099590679781DxH 520B406022019-03-22
10837461001065Iris660-3021660-30212025-04-16
10837461002321Iris800-3215800-32152025-04-16
15099590694968ClearLLab 10CB900022019-04-05
15099590694982ClearLLab 10CB998832019-03-26
15099590701475ClearLLab 10CB968052019-03-26
15099590701482ClearLLab 10CB968062019-03-26
15099590701499ClearLLab 10CB968072019-03-26
15099590701505ClearLLab 10CB968082019-03-26
10837461002031iQ®200 iQ Precision Kit800-30142016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590694968ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-04-05
15099590694982ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590701475ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590701482ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590701499ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590701505ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590670979ClearLLabBECKMAN COULTER IRELAND INC.PWD2017-07-06
15099590670986ClearLLabBECKMAN COULTER IRELAND INC.PWD2017-07-06
15099590670993ClearLLabBECKMAN COULTER IRELAND INC.PWD2017-07-06
15099590671006ClearLLabBECKMAN COULTER IRELAND INC.PWD2017-07-06
15099590671013ClearLLabBECKMAN COULTER IRELAND INC.PWD2017-07-06