510(k) clearances

Biolinq Shine Autonomous Time-in-Range Microsensor

Biolinq Incorporated · Clinical Chemistry

K262599Substantially EquivalentTraditionalSFU
Open FDA's page for this record
Third party flag
N
City
San Diego
Advisory committee description
Clinical Chemistry
Address 1
10260 Sorrento Valley Rd.
Statement or summary
Summary
Product code
SFU
Zip code
92121
Applicant
Biolinq Incorporated
Decision date
2026-09-18
Decision code
SESE
Country code
US
Device name
Biolinq Shine Autonomous Time-in-Range Microsensor
Advisory committee
CH
Contact
Aly Alvarez
K number
K262599
State
CA
Date received
2026-07-27
Review advisory committee
CH
Postal code
92121
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Glucose Range Monitoring System
Medical specialty description
Clinical Chemistry
Regulation number
862.1359
Device class
2
Registration number
2024024, 3025798257
FEI number
2024024, 3025798257
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.