FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAVEN PROPACT
K Number: K053212
·
Decision Feb 15, 2006
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
15
Review Days
91
Basic Information
- Device Name
- RAVEN PROPACT
- K Number
- K053212
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- RAVEN BIOLOGICAL LABORATORIES, INC.
- Date Received
- November 16, 2005
- Decision Date
- February 15, 2006
- Product Code
- MRB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRB | Indicator, Biological, Liquid Chemical Sterilization Process | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRB), ordered by most recent decision date.
SPSMEDICAL SPORVIEW PA CULTURE SET
FDA 510(k)
FDA Class 2
·General Hospital
SPSMEDICAL SPORVIEW PA CULTURE SET
FDA 510(k)
FDA Class 2
·General Hospital
PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by RAVEN BIOLOGICAL LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K082756 | RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR | Oct 21, 2009 | Substantially Equivalent |
| K062651 | PROCHEM EXT CHEMICAL INTEGRATOR | Mar 15, 2007 | Substantially Equivalent |
| K050591 | MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS | Mar 23, 2005 | Substantially Equivalent |
| K041784 | RAVEN PROTEST - EO | Sep 13, 2004 | Substantially Equivalent |
| K041386 | RAVEN PROTEST - STEAM | Aug 9, 2004 | Substantially Equivalent |
| K032914 | MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS | May 25, 2004 | Substantially Equivalent |
| K031114 | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | Mar 3, 2004 | Substantially Equivalent |
| K020026 | RAVEN BACTERIAL SPORE STRIPS | Jan 30, 2002 | Substantially Equivalent |
| K994381 | PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR | Mar 30, 2001 | Substantially Equivalent |
| K971430 | PROSPORE II | May 22, 1997 | Substantially Equivalent |