Skip to content

On Call® Sure Blood Ketone Strips Ogs-511

by Acon Laboratories, Inc. 3 variants

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 Number00682607815258 UDI-DI Date31 Jul 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  • Withdrawn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
On Call® Sure Blood Ketone Strips
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use
Model / Ref / Catalog
OGS-511, GK135-201-104
Primary DI / UDI-DI
00682607815258
510(k) Number
FDA Product Code
JIN, NBW
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, home-use
Device Class
Class I
Regulation Number
862.1435, 862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250085)

Other devices from Acon Laboratories, Inc.

See all devices from Acon Laboratories, Inc. →

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

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