FDA.reportPublic FDA data

CURO L5 Meter

Primary DI
08809115905406
Brand
CURO L5 Meter
Company
OSANG HEALTHCARE Co., Ltd.
Model
ILM-0001A
Published
2021-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CHHEnzymatic Esterase--Oxidase, Cholesterol
JGYColorimetric Method, Triglycerides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1
JGYColorimetric Method, TriglyceridesClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130295000LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.Infopia Co, Ltd.2013-06-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809115905406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809115905406088091159054068809115905406

GMDN Terms#

Term, Definition table
TermDefinition
Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative measurement of total cholesterol lipid in a clinical specimen within a short period relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-930-0030support@curofit.com

Regulatory Flags#

DUNS number
688195374
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809115905796Oh'care Lite Smart Glucose Test StripIGM-1003F2020-11-05
08809115908438Element™ Test StripsIGM-0021B2017-12-11
08809115908957Element™Plus Test StripsIGM-0021B2017-07-21
08809115905369OKRA Glucose Test Strip(25T)IGM-1003A2021-07-27
08809115905697OKRA Glucose Test Strip Refill kitIGM-1003A2020-10-29
08809115905710OKRA Glucose Test StripIGM-1003A2020-10-29
08809115906540Oh'Care Lite Smart Glucose Test StripIGM-1003F2019-09-17
00793150629787Oh’Care Lite Blood Glucose Test stripsIGM-1003AINFS003L2017-11-03
08809115900449QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC02ENA12025-03-18
08809115900401QuickFinder™ COVID-19/Flu Antigen Pro Control Swab KitOI-01SQ-C1RCQC110ENA12025-03-12
08809115900418QuickFinder™ COVID-19/Flu Antigen ProTestOI-01SU-CCRCUCC25ENP12025-03-18
08809115900425QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC05ENA12025-03-18
08809115900432QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC04ENA12025-03-18
08809115900456QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC01ENA12025-03-17
08809115904119CURO L5 Glucose test stripILM-0001AINFSG001EF2022-09-26
08809115905413CURO L5 TC test stripILM-0001A2021-07-09
08809115905444CURO L5 TG test stripILM-0001A2021-06-17
08809115905703OKRA Glucose monitoring system starter kitIGM-1003A2020-10-29
08809115905727OKRA Glucose meterIGM-1003A2020-10-29
00793150629794Oh’Care Lite Glucose Control SolutionIGM-1003AINFCN003L2020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816042016387FORAFORA CARE INC.CHH2026-04-27
00850014861834heartscare Total Cholesterol Test Strip (10pcs/box)Hearts Bio, Inc.CHH2026-04-17
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.CHH2026-03-09
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.JGY2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.CHH2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.JGY2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.CHH2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.JGY2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.JGY2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.JGY2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.CHH2026-03-09
10682607690074Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.JGY2026-03-09
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONCHH2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONCHH2025-10-30
04719893233834XPER Technology Procheck Witty Procheck Smart Total Cholesterol Test StripsTAIDOC TECHNOLOGY CORPORATIONCHH2025-10-30
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.CHH2025-07-02
00381934770017CholesterolPOLYMER TECHNOLOGY SYSTEMS, INC.CHH2025-06-16
10381934770014CholesterolPOLYMER TECHNOLOGY SYSTEMS, INC.CHH2025-06-16
00380740158125AlinityABBOTT IRELANDCHH2025-04-15
00380740158132ARCHITECTABBOTT IRELANDCHH2025-04-15
00380740158149ARCHITECTABBOTT IRELANDCHH2025-04-15
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.CHH2025-03-31
00816042015205FORAFORA CARE INC.CHH2025-03-14
80816042015201FORAFORA CARE INC.CHH2025-03-14
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.CHH2024-07-12
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.JGY2024-07-12
08806141303701Newfoundland Cholesterol TestDFI CO.,LTDCHH2024-05-29
00850053916083IDG/SanzayIDG/SANZAY CorporationCHH2024-01-09