The following data is part of a premarket notification filed by Janssen Pharmaceutica Nv with the FDA for Idylla Respiratory (ifv-rsv) Panel.
| Device ID | K163628 |
| 510k Number | K163628 |
| Device Name: | Idylla Respiratory (IFV-RSV) Panel |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | JANSSEN PHARMACEUTICA NV TURNHOUTSEWEG 30 Beerse, BE 2340 |
| Contact | Sarah Parsons |
| Correspondent | Sarah Parsons JANSSEN RESEARCH & DEVELOPMENT LLC 920 US HIGHWAY 202 Raritan, NJ 08869 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15415219000635 | K163628 | 000 |