RHEUMAGEN CRP T-CONTROL— 510(k) K904312
Substantially EquivalentBiokit USA, Inc.
FDA 510(k) clearance K904312 for RHEUMAGEN CRP T-CONTROL, Substantially Equivalent on 1990-10-01. Applicant: Biokit USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Biokit USA, Inc.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barcelona, ES
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