CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
FDA 510(k) clearance K002401 · decided 2000-08-29
Clearance details
- K-number
- K002401
- Device name
- CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2000-08-07
- Decision date
- 2000-08-29
- Days to decision
- 22 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CIDEX OPA Solution, ortho-Phthalaldehyde Solution recall (Z-0051-05) | Advanced Sterilization Products | 2004-10-28 |