FDA.reportPublic FDA data

CURO A1c

Primary DI
00850006113040
Brand
CURO A1c
Company
KPI HEALTHCARE, INC.
Model
CURO A1c
Device description
CURO A1c Daily Check Cartridge
Published
2019-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082275000CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023Infopia Co, Ltd.2010-01-14LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006113040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006113040008500061130408500061130400850006113040

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump/interstitial glucose monitoring systemAn assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
087243403
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006113026CURO A1cCURO A1c2019-04-26
00850006113033CURO A1cCURO A1c2019-04-26
00850006113064Curo L5Curo L52019-04-26
00860394001225CURO L5CURO L5 CURO L52019-04-26
00860394001232CURO B3CURO B32019-04-26
00860394001249CURO G6s Smart Glucose MeterCURO G6s Smart Glucose Meter2019-04-26
00860394001256CURO L5 Total Cholesterol StripsCURO L5 Total Cholesterol Strips2019-04-26
00860394001263CURO G6 Glucose MeterCURO G6 Glucose Meter2019-04-26
00860394001270Curo A1c AnalyzerCuro A1c Analyzer2019-04-26
00860394001294CURO Glucose StripsCURO Glucose Strips2019-04-26

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