CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196— 510(k) K041174
Substantially EquivalentSweden Diagnostics (Germany) GmbH
FDA 510(k) clearance K041174 for CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196, Substantially Equivalent on 2004-07-19. Applicant: Sweden Diagnostics (Germany) GmbH. Device class: 2.
Clearance details
- Applicant
- Sweden Diagnostics (Germany) GmbH
- Product code
- Code MVM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg, DE
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More clearances from Sweden Diagnostics (Germany) GmbH
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