The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia Smdp Immunoassay.
Device ID | K183007 |
510k Number | K183007 |
Device Name: | EliA SmDP Immunoassay |
Classification | Anti-sm Antibody, Antigen And Control |
Applicant | Phadia AB Rapsgatan 7P Uppsala, SE Se 754 50 |
Contact | Carina Magnusson |
Correspondent | Sheryl Skinner Phadia US Inc. 4169 Commercial Avenue Portage, MI 49002 |
Product Code | LKP |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-31 |
Decision Date | 2018-12-24 |
Summary: | summary |