The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Gmbh with the FDA for Innovance Free Ps Ag.
| Device ID | K181525 |
| 510k Number | K181525 |
| Device Name: | INNOVANCE Free PS Ag |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Strasse 76 Marburg, DE 35041 |
| Contact | Petra Dissmann |
| Correspondent | Petra Dissmann Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Strasse 76 Marburg, DE 35041 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2018-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768039522 | K181525 | 000 |
| 00630414639826 | K181525 | 000 |