FDA.reportPublic FDA data

Synchron

Primary DI
15099590222727
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
465993
Catalog number
465993
Device description
SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 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
DKCAlcohol Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKCAlcohol Control MaterialsClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934467000BECKMAN CX AMMONIA/ALCOHOL CONTROLBeckman-Diagnostic Systems Group1993-10-27DKC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590222727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022272715099590222727

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together may create a full general biochemistry profile.

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
15099590799243MicroScanV5.03 PU11ED233522025-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727017420Pointe Ethyl Alcohol Level 1 Control (50 mg/dL)HORIBA INSTRUMENTS INCORPORATEDDKC2020-09-25
00811727017437Pointe Ethyl Alcohol Level 2 Control (300 mg/dL)HORIBA INSTRUMENTS INCORPORATEDDKC2020-09-25
04250317544742Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317546067Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317546111Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317535771Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317535788Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317535795Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317544971Serum ControlChromsystems Instruments + Chemicals GmbHDKC2020-07-30
04250317545213Serum ControlChromsystems Instruments + Chemicals GmbHDKC2020-07-30
04250317502209Serum ControlChromsystems Instruments + Chemicals GmbHDKC2020-07-30
04250317502223Serum ControlChromsystems Instruments + Chemicals GmbHDKC2020-07-30
00817238011568WHOLE BLOOD ETHANOL CONTROL LEVEL1CLINIQA CORPORATIONDKC2018-08-23
00817238011575WHOLE BLOOD ETHANOL CONTROL LEVEL 2 CLINIQA CORPORATIONDKC2018-08-23
00380740135379AlinityABBOTT LABORATORIESDKC2018-07-11
00884883001015DRI 50 mg/dL Alcohol ControlMicrogenics CorporationDKC2017-10-30
00884883001039DRI 300 mg/dL Alcohol ControlMicrogenics CorporationDKC2017-10-30
00840937110683ImmunalysisIMMUNALYSIS CORPDKC2017-10-24
00840937110409ImmunalysisIMMUNALYSIS CORPDKC2017-09-07
00884883005129DRI Negative Alcohol CalibratorMicrogenics CorporationDKC2016-09-12
00884883005198DRI 100 mg/dL Alcohol Calibrator Microgenics CorporationDKC2016-09-12
00884883011540DRI 100 mg/dL Alcohol Calibrator Microgenics CorporationDKC2016-09-12
00884883011564DRI Negative Alcohol CalibratorMicrogenics CorporationDKC2016-09-12
00817302021332CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021349CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021356CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021363CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021370CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021387CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
15099590222710SynchronBeckman Coulter, Inc.DKC2016-08-24