FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
K Number: K051056
·
Decision Oct 20, 2005
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
19
Review Days
177
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Basic Information
- Device Name
- VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
- K Number
- K051056
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Albert Browne , Ltd.
- Date Received
- April 26, 2005
- Decision Date
- October 20, 2005
- Product Code
- FRC
- 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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Other Clearances by Albert Browne , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K063285 | RELIANCE CI PROCESS INDICATOR | Jan 12, 2007 | Substantially Equivalent |
| K061738 | ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD | Aug 25, 2006 | Substantially Equivalent |
| K053479 | VERIFY DRY HEAT LABEL | Jul 18, 2006 | Substantially Equivalent |
| K060066 | VERIFY 3-10 MIN FLASH INTEGRATOR | Mar 24, 2006 | Substantially Equivalent |
| K060103 | ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS | Mar 7, 2006 | Substantially Equivalent |
| K051101 | VERIFY FLASH INTEGRATOR | Dec 6, 2005 | Substantially Equivalent |
| K032801 | MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR | Oct 17, 2003 | Substantially Equivalent |
| K002741 | BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK | Jul 3, 2002 | Substantially Equivalent |
| K002937 | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | Nov 5, 2001 | Substantially Equivalent |
| K012335 | BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS | Oct 1, 2001 | Substantially Equivalent |