EZ-BEAD DIGOXIN EIA KIT
FDA 510(k) clearance K893843 · decided 1989-09-28
Clearance details
- K-number
- K893843
- Device name
- EZ-BEAD DIGOXIN EIA KIT
- Applicant
- Immunotech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-25
- Decision date
- 1989-09-28
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- KXT
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.