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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
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04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
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06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
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