FDA.reportPublic FDA data

Mission Cholesterol Optical Check Device

Primary DI
10682607690074
Brand
Mission Cholesterol Optical Check Device
Company
Acon Laboratories, Inc.
Model
C121-2021
Catalog number
C121-2021
Device description
Meter optics checker
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JGYCOLORIMETRIC METHOD, TRIGLYCERIDES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGYColorimetric Method, TriglyceridesClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163406000Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.2017-07-11CHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10682607690074PackageGS112In Commercial Distribution
20682607690071PackageGS14In Commercial Distribution
00682607690077PrimaryGS10
00682607003679Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068260769007410682607690074
2068260769007120682607690071
00682607690077006826076900776826076900770682607690077
00682607003679006826070036796826070036790682607003679

GMDN Terms#

Term, Definition table
TermDefinition
Total cholesterol lipid IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cholesterol lipid in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)838-9502support@aconlabs.com

Regulatory Flags#

DUNS number
781100966
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1012026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1042026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1052026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1012026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1022026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1042026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1052026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONOGS-211G125-22U-1012026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMOGM-211G115-20U-1012026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-21U-1012026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-22U-1012026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-23U-1012026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMOGM-212G115-20W-1012026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-21W-1012026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-22W-1012026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-23W-1012026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMOGM-511GK115-201-1012026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METEROGM-511GK115-221-1012026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMOGM-512GK115-222-1012026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONOGC-511GK125-221-1012026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.JGY2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.JGY2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.JGY2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.JGY2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.JGY2026-03-09
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.JGY2024-07-12
00893038002913Cholestech LDX™Alere San Diego, Inc.JGY2023-12-20
00893038002937Cholestech LDX™Alere San Diego, Inc.JGY2023-12-20
06936895301929BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGY2023-07-26
06936895301936BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGY2023-07-26
06936895301943BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGY2023-07-26
06936895301950BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGY2023-07-26
00381934753010Lipid Panel, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.JGY2023-06-20
10381934753017Lipid Panel, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.JGY2023-06-20
00381934752013Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)POLYMER TECHNOLOGY SYSTEMS, INC.JGY2023-06-01
00887473000337STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.JGY2023-05-10
00887473000344STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.JGY2023-05-10
00887473000320STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.JGY2023-04-07
00381934747019Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.JGY2023-03-25
00381934749013Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.JGY2023-03-25
00887473000290STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.JGY2023-03-17
00887473000306STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.JGY2023-03-17
00887473000283STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.JGY2023-03-17
00381934750019CardioChek Plus Home Self-Test AnalyzerPOLYMER TECHNOLOGY SYSTEMS, INC.JGY2022-04-11
08809115905406CURO L5 MeterOSANG HEALTHCARE Co., Ltd.JGY2021-07-09
08809115905444CURO L5 TG test stripOSANG HEALTHCARE Co., Ltd.JGY2021-06-17
00381934721019CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ctPOLYMER TECHNOLOGY SYSTEMS, INC.JGY2021-02-08
00381934722016CardioChek Plus Home Lipid Panel Self-Test Strip 2ctPOLYMER TECHNOLOGY SYSTEMS, INC.JGY2021-02-08