FDA.reportPublic FDA data

Synchron

Primary DI
15099590225346
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
475089
Catalog number
475089
Device description
SYNCHRON Systems MA Calibrator
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000331000SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATORBeckman Coulter, Inc.2000-02-10JIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590225346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022534615099590225346

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of albumin in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750033539VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-12-30
15099590754495Access Total T4 II CalibratorsBeckman Coulter, Inc.JIS2025-09-19
10758750035373VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-05-20
20758750035370VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-05-20
05051700020534Optilite® Low Level Total Protein CalibratorTHE BINDING SITE GROUP LIMITEDJIS2024-10-30
00816426021532K-ASSAY® RF Calibrator (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCJIS2024-04-17
00630414615097Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIS2024-04-03
00630414313450Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIS2024-04-03
00630414639833INNOVANCE Heparin CalibratorSiemens Healthcare Diagnostics Products GmbHJIS2024-03-25
15099590752699Access Progesterone II CalibratorsBeckman Coulter, Inc.JIS2024-03-01
00630414611297Atellica CH RCRP CalSiemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414636672Atellica CH Protein 1 Calibrator (PROT 1 CAL)Siemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414305141Atellica CH RCRP CalSiemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414313467Atellica CH Protein 1 Calibrator (PROT 1 CAL)Siemens Healthcare Diagnostics Inc.JIS2024-02-02
10758750034635VITROSORTHO CLINICAL DIAGNOSTICSJIS2024-01-20
20758750034632VITROSORTHO CLINICAL DIAGNOSTICSJIS2024-01-20
00380740197636AlinityAbbott GmbHJIS2023-11-04
07613336203538Anti-Tg CalSetRoche Diagnostics GmbHJIS2023-10-31
07613336175088CalSet FT4 IVRoche Diagnostics GmbHJIS2023-05-02
10758750033799VITROSORTHO CLINICAL DIAGNOSTICSJIS2023-03-28
10758750033850VITROSORTHO CLINICAL DIAGNOSTICSJIS2023-03-28
03607360047606CDT CAPILLARYS CALIBRATORS (2 Levels)SEBIAJIS2022-12-12
03607360047613CDT MINICAP CALIBRATORS ( 2 Levels)SEBIAJIS2022-12-12
10758750034642VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-26
10758750034659VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-24
10758750034895VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-24
05055273204445LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) RANDOX LABORATORIES LIMITEDJIS2022-10-05
00817302024340CAROLINA LIQUID CHEMISTRIES CORP.® IRON STANDARD (FESTD) CC618-STDCAROLINA LIQUID CHEMISTRIES CORPORATIONJIS2022-08-19
00630414610863Atellica CH HDLC CALSiemens Healthcare Diagnostics Inc.JIS2022-07-08
00630414305165Atellica CH HDLC CALSiemens Healthcare Diagnostics Inc.JIS2022-07-08