FDA.reportPublic FDA data

Synchron

Primary DI
15099590200039
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
469630
Catalog number
469630
Device description
SYNCHRON Systems Drug Calibrator 2
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
K993473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993473000SYNCHRON SYSTEMS DRUG CALIBRATOR 2Beckman Coulter, Inc.1999-11-26DLJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590200039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959020003915099590200039

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-therapy therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) 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
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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