FDA.reportPublic FDA data

CURO L7 Analyzer

Primary DI
08809319396161
Brand
CURO L7 Analyzer
Company
SD Biosensor, Inc.
Model
99LA10G-2
Published
2020-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
CHHEnzymatic Esterase--Oxidase, Cholesterol
JGYColorimetric Method, Triglycerides
LBRLdl & Vldl Precipitation, Hdl
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1
JGYColorimetric Method, TriglyceridesClinical Chemistry1
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160282000SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home SystemSd Biosensor2017-10-17NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809319396161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809319396161088093193961618809319396161

GMDN Terms#

Term, Definition table
TermDefinition
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557812789
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887473000290STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile02LS10C2023-03-17
00887473000306STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile02LS10B2023-03-17
00887473000337STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile02LS10C2023-05-10
00887473000344STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile02LS10B2023-05-10
00887473000320STANDARD™ LipidoCare Analyzer02LA10G2023-04-07
00887473000283STANDARD™ LipidoCare Analyzer02LA20G2023-03-17
00887473000313STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile02LS10B2023-03-17
08809319396512CURO L7 Lipid Test Strip - Lipid Profile99LS10-22020-04-21
00887473000122SD GlucoNavii Blood Glucose Test Strip01GS11C2017-03-23
00887473000009SD GlucoNavii Blood Glucose Monitoring System01GC1112017-03-23
00887473000016SD GlucoNavii Blood Glucose Monitoring System01GM112017-03-23
00887473000108SD GlucoNavii Blood Glucose Monitoring System01GC1102017-03-23
0887473000115SD GlucoNavii Blood Glucose Test Strip01GS11C2017-03-23
00887473000139SD Glucose Control Solution 01GCS102017-03-23
00887473000160SD GlucoNavii Blood Glucose Test Strip01GS112017-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
00010939958693TRUE METRIXTRIVIDIA HEALTH, INC.NBW2023-09-12
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
08809115905406CURO L5 MeterOSANG HEALTHCARE Co., Ltd.JGY2021-07-09
14987481164533L-Type LDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
14987481164540L-Type LDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22