The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti-m2-3e Elisa (igg).
Device ID | K092736 |
510k Number | K092736 |
Device Name: | EUROIMMUN ANTI-M2-3E ELISA (IGG) |
Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
Applicant | EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
Contact | Kathryn Kohl |
Correspondent | Kathryn Kohl EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
Product Code | DBM |
CFR Regulation Number | 866.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-04 |
Decision Date | 2010-09-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04049016027157 | K092736 | 000 |