Mission Cholesterol Meter

Basic Information

• Brand Name: Mission Cholesterol Meter
• Primary DI: 00682607690060
• Version / Model: C111-2021
• Catalog Number: C111-2021
• Company Name: Acon Laboratories, Inc.
• Labeler DUNS: 781100966
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-09
• Public Version: 1
• Public Version Date: 2026-03-17
• Public Version Status: New
• Public Device Record Key: 1db17b00-f822-44c4-9ddb-7142a2d2ab5a

Device Description

Cholesterol meter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JGY	COLORIMETRIC METHOD, TRIGLYCERIDES	Clinical Chemistry	862.1705	1
LBR	LDL & VLDL PRECIPITATION, HDL	Clinical Chemistry	862.1475	1
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL	Clinical Chemistry	862.1175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53359	Total cholesterol lipid IVD, kit, spectrophotometry	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00682607690060	GS1

Customer Contacts

• Phone: [phone] ext. 1
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K163406	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit