The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Eia Smdp Immunoassay.
| Device ID | K132631 |
| 510k Number | K132631 |
| Device Name: | EIA SMDP IMMUNOASSAY |
| Classification | Anti-sm 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 | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-22 |
| Decision Date | 2014-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010885 | K132631 | 000 |