STERRAD CHEMIAL INDICATOR STRIP MODEL 14100— 510(k) K111518
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K111518 for STERRAD CHEMIAL INDICATOR STRIP MODEL 14100, Substantially Equivalent on 2012-10-03. Applicant: Advanced Sterilization Products. Device class: 2.
Clearance details
- Applicant
- Advanced Sterilization Products
- Product code
- 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
- Irvin, CA, US
Recent devices under product code JOJ
view all- K260181 — LF Process Indicator Tape for Steam Sterilization
- K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more
- K251035 — DISINTEK PA Test Strips
- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
- K243876 — VERIFY STEAM Integrating Indicator
More clearances from Advanced Sterilization Products
view all- K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more
- K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
- K162007 — STERRAD NX Sterilizer
- K160818 — STERRAD® NX Sterilizer with ALLClear Technology
- K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology
Data sourced from openFDA. This site is unofficial and independent of the FDA.