WAKO AUTOKIT LP(A)/DADE DEMENSION
FDA 510(k) clearance K001919 · decided 2000-07-23
Clearance details
- K-number
- K001919
- Device name
- WAKO AUTOKIT LP(A)/DADE DEMENSION
- Applicant
- Wako Chemicals USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-23
- Decision date
- 2000-07-23
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DFC
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Richmond, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.