Indicator, Biological, Liquid Chemical Sterilization Process
The Biological Indicator for Liquid Chemical Sterilization Processes is a general hospital device used to validate that a liquid chemical sterilization process (such as glutaraldehyde or peracetic acid sterilization) has achieved the required level of microbial kill, using resistant microorganisms as a biological challenge. Classified as FDA Class 2 under 21 CFR 880.2800, it requires 510(k) premarket notification. The product code is MRB, and it is eligible for third-party 510(k) review.
Basic Information
- Product Code
- MRB
- Device Class
- FDA class 2
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K081879 | SPSMEDICAL SPORVIEW PA CULTURE SET | Jul 30, 2008 | Substantially Equivalent | SPS MEDICAL SUPPLY CORP. |
| K053212 | RAVEN PROPACT | Feb 15, 2006 | Substantially Equivalent | RAVEN BIOLOGICAL LABORATORIES, INC. |
| K043135 | SPSMEDICAL SPORVIEW PA CULTURE SET | Jan 13, 2005 | Substantially Equivalent | SPS MEDICAL SUPPLY CORP. |
| K031114 | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | Mar 03, 2004 | Substantially Equivalent | RAVEN BIOLOGICAL LABORATORIES, INC. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.