SERODIA ATG— 510(k) K953066
Substantially EquivalentFujirebio America, Inc.
FDA 510(k) clearance K953066 for SERODIA ATG, Substantially Equivalent on 1995-08-14. Applicant: Fujirebio America, Inc.. Device class: 2.
Clearance details
- Applicant
- Fujirebio America, Inc.
- Product code
- Code DDC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Cadwell, NJ, US
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