TAN DEM* - IGE KIT— 510(k) K802913
Substantially EquivalentHybritech, Inc.
FDA 510(k) clearance K802913 for TAN DEM* - IGE KIT, Substantially Equivalent on 1981-05-29. Applicant: Hybritech, Inc.. Device class: 2.
Clearance details
- Applicant
- Hybritech, Inc.
- 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
- Mchenry, IL, US
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