The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia Smdp-s.
Device ID | K202067 |
510k Number | K202067 |
Device Name: | EliA SmDP-S |
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 | 2020-07-27 |
Decision Date | 2021-07-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07333066017709 | K202067 | 000 |