BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE
FDA 510(k) clearance K922481 · decided 1994-06-02
Clearance details
- K-number
- K922481
- Device name
- BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE
- Applicant
- Board of Directors, Albert Browne , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-26
- Decision date
- 1994-06-02
- Days to decision
- 737 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Leics. Le4 Oaa, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products'' recall (Z-1480-04) | Advanced Sterilization Products | 2004-09-21 |
| Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek recall (Z-0712-03) | Sybron Dental Specialties | 2003-04-09 |
| Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips. recall (Z-0694-03) | Advanced Sterilization Products | 2003-03-29 |