FDA.reportPublic FDA data

Tyson Bio AC500 Blood Glucose Meter

Primary DI
04719869702968
Brand
Tyson Bio AC500 Blood Glucose Meter
Company
TYSON BIORESEARCH INC.
Model
AC500
Published
2020-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123087000TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEMTyson Bioresearch, Inc.2013-06-18NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719869702968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719869702968047198697029684719869702968

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658026104
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719869700667EZ Smart-608 Blood Glucose Test Strips (50T)EZ Smart-6082017-09-26
04719869701053TysonBio EVOLVE Blood Glucose Test Strips (25T)TysonBio EVOLVE2017-09-26
04719869701060TysonBio EVOLVE Blood Glucose Test Strips (50T)TysonBio EVOLVE2017-09-26
04719869701824Tyson Bio HT100 Blood Glucose Test Strip , 25THT1002018-07-17
04719869701831Tyson Bio HT100 Blood Glucose Test Strip , 50THT1002018-07-17
04719869701978Tyson Bio HT100-B Blood Glucose Test Strip , 50THT100-B2020-08-11
04719869701985Tyson Bio HT100-B Blood Glucose Test Strip, 25THT100-B2020-08-11
04719869702333Tyson Bio 50H Blood Glucose Test Strip, 25TTyson Bio 50H2019-03-11
04719869702340Tyson Bio 50H Blood Glucose Test Strip, 50TTyson Bio 50H2019-03-11
04719869703118TysonBio AC500 Blood Glucose Test Strips, 50TAC5002020-04-15
04719869703125TysonBio AC500 Blood Glucose Test Strips, 25TAC5002020-04-15
04719869705884Tyson Bio HS100 Blood Glucose Test StripsHS1002024-11-11
04719869705891Tyson Bio HS100 Blood Glucose Test StripsHS100 2024-11-11
04719869701992Tyson Bio HT100-B Blood Glucose Test Strip , 10THT100-B2020-08-11
04719869703132TysonBio AC500 Blood Glucose Test Strips, 10TAC5002020-04-15
04719869701497TysonBio AC200 Blood Glucose Test Strips (50T)TysonBio AC2002017-09-26
04719869701503TysonBio AC200 Blood Glucose Test Strips (25T)TysonBio AC2002017-09-26
04719869701961Tyson Bio HT100 Blood Glucose Test Strip, 10THT1002018-07-17
04719869702326Tyson Bio 50H Blood Glucose Test Strip, 10TTyson Bio 50H2019-03-11
04719869702395TysonBio AC200 Blood Glucose Test Strip, 10TTysonBio AC2002019-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19