BROWNE GA INDICATOR FOR CIDEX PRODUCTS
FDA 510(k) clearance K981054 · decided 1998-12-07
Clearance details
- K-number
- K981054
- Device name
- BROWNE GA INDICATOR FOR CIDEX PRODUCTS
- Applicant
- Albert Browne , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-23
- Decision date
- 1998-12-07
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cidexplus Solution Test Strips recall (Z-0779-05) | Advanced Sterilization Products | 2005-04-27 |
| Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX PLUS Products'' recall (Z-1479-04) | Advanced Sterilization Products | 2004-09-21 |
| Cidex Plus Solution Test Strips recall (Z-0695-03) | Advanced Sterilization Products | 2003-03-29 |