FDA.reportPublic FDA data

Embrace Pro Control Solution

Primary DI
08806128340002
Brand
Embrace Pro Control Solution
Company
All Medicus Co.,Ltd.
Model
AGM-4000
Published
2016-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
LFRGlucose Dehydrogenase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083628000GLUCODR AUTO SYSTEMAll Medicus Co., Ltd.2009-05-01NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806128340002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806128340002088061283400028806128340002

GMDN Terms#

Term, Definition table
TermDefinition
Home-use/point-of-care blood glucose monitoring system IVDA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Regulatory Flags#

DUNS number
688022826
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
08806128351534metene Blood Glucose Test StripAGM-513S2021-12-24
08806128351503metene Control SolutionAGM-513S2021-12-24
08806128351541metene Blood Glucose Test StripAGM-513S2021-12-24
08806128351565metene Blood Glucose Test MeterAGM-513S2021-12-24
08806128351589metene Blood Glucose Monitoring SystemAGM-513S2021-12-24
08806128340019Embrace Pro Blood Glucose Test StripAGM-40002016-12-23
08806128340064Embrace Pro Blood Glucose Test MeterAGM-40002016-12-23

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