STERRAD Chemical Indicator (CI) Strip (14100) +5 more— 510(k) K234084
Substantially EquivalentAdvanced Sterilization Products, Inc.
FDA 510(k) clearance K234084 for STERRAD Chemical Indicator (CI) Strip (14100) +5 more, Substantially Equivalent on 2024-07-05. Applicant: Advanced Sterilization Products, Inc.. Device class: 2.
Clearance details
- Device name as filed
- STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count)
- Applicant
- Advanced Sterilization Products, Inc.
- 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
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