K251035

Substantially Equivalent

DISINTEK PA Test Strips

Applicant: Serim Research
Product code: JOJ
Advisory panel: General Hospital
Date received: 2025-04-03
Decision date: 2025-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.