MRB — Indicator, Biological, Liquid Chemical Sterilization Process Class II
FDA product code MRB covers "Indicator, Biological, Liquid Chemical Sterilization Process", a Class II medical device regulated under 21 CFR 880.2800. Submissions are reviewed by the General Hospital panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MRB
- 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 |
|---|---|---|---|
| K081879 | spsmedical supply | SPSMEDICAL SPORVIEW PA CULTURE SET | July 30, 2008 |
| K053212 | raven biological laboratories | RAVEN PROPACT | February 15, 2006 |
| K043135 | spsmedical supply | SPSMEDICAL SPORVIEW PA CULTURE SET | January 13, 2005 |
| K031114 | raven biological laboratories | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | March 3, 2004 |