SENSIBEAD EIA IGE KIT— 510(k) K840674
Substantially EquivalentTerumo Medical Corp.
FDA 510(k) clearance K840674 for SENSIBEAD EIA IGE KIT, Substantially Equivalent on 1984-04-04. Applicant: Terumo Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Medical Corp.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkton, MD, US
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