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Mission Cholesterol Optical Check Device C121-2021

by Acon Laboratories, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00682607690077 UDI-DI Date9 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Mission Cholesterol Optical Check Device
Generic Name
Total cholesterol lipid IVD, kit, spectrophotometry
Model / Ref / Catalog
C121-2021
Primary DI / UDI-DI
00682607690077
510(k) Number
FDA Product Code
JGY, CHH, LBR
GMDN Term
Total cholesterol lipid IVD, kit, spectrophotometry
Device Class
Class I
Regulation Number
862.1705, 862.1175, 862.1475
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K163406)

Other devices from Acon Laboratories, Inc.

See all devices from Acon Laboratories, Inc. →

Properties

  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No