CIDEX ACTIVATED DIALDEHYDE SOLUTION
FDA 510(k) clearance K060618 · decided 2006-04-12
Clearance details
- K-number
- K060618
- Device name
- CIDEX ACTIVATED DIALDEHYDE SOLUTION
- Applicant
- Johnson & Johnson Co.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-08
- Decision date
- 2006-04-12
- Days to decision
- 35 days
- Clearance type
- Special
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Johnson & Johnson Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 recall (Z-2459-2015) | Advanced Sterilization Products | 2015-08-25 |