LRT — Indicator, Sterilization Class II
FDA product code LRT covers "Indicator, Sterilization", a Class II medical device regulated under 21 CFR 880.2800. Submissions are reviewed by the General Hospital panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LRT
- Device Class
- Class II
- Regulation Number
- 880.2800
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K002937 | albert browne | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | November 5, 2001 |
| K965154 | albert browne | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE | September 19, 1997 |
| K951113 | steritec products mfg co | CROSS-CHECKS | August 19, 1996 |
| K951703 | products for medicine | TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS | June 28, 1995 |
| K871672 | propper mfg. co | STERILIZATION INDICATOR FOR FLASH STERILIZATION | June 1, 1987 |