The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia M2; Immunoassay, Positive Control 100, Positive Control 250.
| Device ID | K141375 |
| 510k Number | K141375 |
| Device Name: | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | PHADIA US INC. MUNZINGER STRASSE 7 Freiburg Im Breisgau, DE 79111 |
| Contact | Manuela Constanze Hog |
| Correspondent | Manuela Constanze Hog PHADIA US INC. MUNZINGER STRASSE 7 Freiburg Im Breisgau, DE 79111 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2015-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010908 | K141375 | 000 |
| 07333066014326 | K141375 | 000 |
| 07333066014319 | K141375 | 000 |