DISINTEK PA Test Strips
K-Number: K251035 · 2025-06-03
ApplicantSerim Research
Decision Date2025-06-03
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
DISINTEK PA Test Strips is a medical device manufactured by Serim Research. It received FDA 510(k) clearance on 2025-06-03 under approval number K251035. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DISINTEK PA Test Strips?
DISINTEK PA Test Strips is a medical device that received FDA 510(k) clearance on 2025-06-03. It is manufactured by Serim Research. The 510(k) number is K251035.
When was DISINTEK PA Test Strips approved by the FDA?
DISINTEK PA Test Strips received FDA 510(k) clearance on 2025-06-03, under approval number K251035.
What company makes DISINTEK PA Test Strips?
DISINTEK PA Test Strips is manufactured by Serim Research.
What is the FDA product code for DISINTEK PA Test Strips?
The FDA product code for DISINTEK PA Test Strips is JOJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.