WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
FDA 510(k) clearance K062368 · decided 2007-01-31
Clearance details
- K-number
- K062368
- Device name
- WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
- Applicant
- Wako Chemicals USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-14
- Decision date
- 2007-01-31
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- OAU
- Device class
- 2
- Regulation number
- 866.6030
- 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.