SENSIBEAD EIA IGE KIT
FDA 510(k) clearance K840674 · decided 1984-04-04
Clearance details
- K-number
- K840674
- Device name
- SENSIBEAD EIA IGE KIT
- Applicant
- Terumo Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-15
- Decision date
- 1984-04-04
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- DGC
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.