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 |