FDA.reportPublic FDA data

Synchron

Primary DI
15099590222017
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
474985
Catalog number
474985
Device description
SYNCHRON Systems OP 300 High Urine 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
DLJCalibrators, Drug Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993022000SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORSBeckman Coulter, Inc.1999-11-09DLJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590222017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022201715099590222017

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
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
00812101031629ARK™ Ketamine II CalibratorARK DIAGNOSTICS INCDLJ2025-12-27
00812101031636ARK™ Ketamine II Calibrator (Negative)ARK DIAGNOSTICS INCDLJ2025-12-27
00812101031643ARK™ Ketamine II Calibrator (50 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00850624008650LZI Fentanyl Qualitative CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2025-10-13
00840937114568ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
00840937114605ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
07613336224830MTX CalibratorRoche Diagnostics GmbHDLJ2024-03-25
00840937103265ImmunalysisIMMUNALYSIS CORPDLJ2023-10-26
00840937103272ImmunalysisIMMUNALYSIS CORPDLJ2023-10-26
00840937103289ImmunalysisIMMUNALYSIS CORPDLJ2023-10-26
00840937103296ImmunalysisIMMUNALYSIS CORPDLJ2023-10-26
00894354002366Beckman CoulterSALADAX BIOMEDICAL, INC.DLJ2022-06-15
B07604120LZI Tramadol Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604130LZI Tramadol Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604140LZI Tramadol Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604150LZI Tramadol High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07605220LZI Cotinine II Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605230LZI Cotinine II Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605240LZI Cotinine II Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605250LZI Cotinine II High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
00894354002212MyCare PsychiatrySALADAX BIOMEDICAL, INC.DLJ2022-01-27
00850624008278Fentanyl Qualitative Calibrator SetLIN-ZHI INTERNATIONAL, INC.DLJ2021-10-18
00812101030509ARK™ HS Benzodiazepine II CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030516ARK™ HS Benzodiazepine II Negative CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030523ARK™ HS Benzodiazepine II 100ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030530ARK™ HS Benzodiazepine II 200ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
B07606250LZI Oxycodone 300 High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-19
B07606120LZI Oxycodone 100 Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-18
B07606130LZI Oxycodone 100 Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-18