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510(k) K251035

DISINTEK™ PA Test Strips by Serim Research — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2025
Date Received
April 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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