The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Rnp70 Immunoassay, Elia Sci-70 Immunoassay And Elia Jo-1 Immunoassay, Models 14-5511-01, 14-5506-01 And 14-5507-01.
| Device ID | K083117 |
| 510k Number | K083117 |
| Device Name: | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 |
| Classification | Anti-rnp Antibody, Antigen And Control |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin Robert Mann |
| Correspondent | Martin Robert Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | LKO |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-22 |
| Decision Date | 2009-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010663 | K083117 | 000 |
| 07333066010625 | K083117 | 000 |
| 07333066010618 | K083117 | 000 |