TRI-LEVEL LIGAND CONTROL
FDA 510(k) clearance K864877 · decided 1987-05-21
Clearance details
- K-number
- K864877
- Device name
- TRI-LEVEL LIGAND CONTROL
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-12
- Decision date
- 1987-05-21
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- DHX
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.