FDA.reportPublic FDA data

Chemistry Analyzer

Primary DI
06944904084459
Brand
Chemistry Analyzer
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
CLC720i
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
CEMElectrode, Ion Specific, Potassium
CGZElectrode, Ion-Specific, Chloride
JGSElectrode, Ion Specific, Sodium
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDQUrease And Glutamic Dehydrogenase, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140690000BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERShenzhen Mindray Bio-Medical Electronics Co., Ltd.2014-09-02CDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944904084459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904084459069449040844596944904084459

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654671304
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936415904661MR Na/K Check Solution105-011386-002026-01-23
06936415904678MR Detergent Solution105-011383-002026-01-23
06936415904685MR Buffer Solution105-011382-002026-01-23
06903053010641M-30CFL LYSEM-30CFL105-026307-002026-01-22
06936415908805M-30CFL LYSEM-30CFL105-006209-002026-01-22
06936415908812M-30CFL LYSEM-30CFL105-006210-002026-01-22
06936415994457PROBE CLEANSERPROBE CLEANSER105-009432-002026-01-22
06944904030210PROBE CLEANSERPROBE CLEANSER105-002225-002026-01-22
06944904093116M-5LEO(I) LyseM-5LEO(I)105-011724-002026-01-22
06944904093123M-5LEO(I) LyseM-5LEO(I)105-011725-002026-01-22
06944904093130M-5LEO(II) LyseM-5LEO(II)105-011729-002026-01-22
06944904093147M-5LEO(II) LyseM-5LEO(II)105-011730-002026-01-22
06944904093154M-53LH LYSEM-53LH105-011734-002026-01-22
06944904093161M-53LH LYSEM-53LH105-011735-002026-01-22
06936415973643VS 9 Vital Signs MonitorVS 92025-01-24
06936415973650VS 8 Vital Signs MonitorVS 82025-01-24
06936415973667VS 8A Vital Signs MonitorVS 8A2025-01-24
06936415972417BeneVision Central Monitoring SystemBeneVision2024-09-24
06944904055152BeneVision Central Monitoring SystemBeneVision115-034413-002015-10-20
06944904055275BeneVision Central Monitoring SystemBeneVision115-034410-002015-10-20

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