Advanced Sterilization Products, Inc. · Class II · Cleared Jul 5, 2024
| K-number | K234084 |
| Device name | 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 | JOJ |
| Device class | Class II |
| Decision date | Jul 5, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 880.2800 |
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