FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BROWNE GA INDICATOR FOR CIDEX PRODUCTS
K Number: K981054
·
Decision Dec 7, 1998
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
19
Review Days
259
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Basic Information
- Device Name
- BROWNE GA INDICATOR FOR CIDEX PRODUCTS
- K Number
- K981054
- 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
- March 23, 1998
- Decision Date
- December 7, 1998
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical 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 |
| K051056 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR | Oct 20, 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 |