The following data is part of a premarket notification filed by Sweden Diagnostics (germany) Gmbh with the FDA for Celikey Ttg (human, Recombinant) Iga Antibodies Model #18148/18196.
| Device ID | K041174 |
| 510k Number | K041174 |
| Device Name: | CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7 Freiburg, DE D-79111 |
| Contact | Michael Linss |
| Correspondent | Michael Linss SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7 Freiburg, DE D-79111 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-05 |
| Decision Date | 2004-07-19 |
| Summary: | summary |