TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS
FDA 510(k) clearance K851891 · decided 1985-07-19
Clearance details
- K-number
- K851891
- Device name
- TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS
- Applicant
- Richard Scott Elliott
- Decision
- Substantially Equivalent
- Date received
- 1985-04-30
- Decision date
- 1985-07-19
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- LOJ
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Salem, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.