DISINTEK PA Test Strips— 510(k) K251035
Substantially EquivalentSerim Research
FDA 510(k) clearance K251035 for DISINTEK PA Test Strips, Substantially Equivalent on 2025-06-03. Applicant: Serim Research. Device class: 2.
Clearance details
- Applicant
- Serim Research
- Product code
- Product code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
Recent devices under product code JOJ
view all- K263267 — Endox Test Strips
- K261992 — 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
- K260181 — LF Process Indicator Tape for Steam Sterilization
- K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more
- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
More clearances from Serim Research
view allData sourced from openFDA. This site is unofficial and independent of the FDA.