The following data is part of a premarket notification filed by Verum Diagnostica Gmbh with the FDA for Multiplate 5.0 Aggregometer.
| Device ID | K103555 |
| 510k Number | K103555 |
| Device Name: | MULTIPLATE 5.0 AGGREGOMETER |
| Classification | System, Automated Platelet Aggregation |
| Applicant | VERUM DIAGNOSTICA GMBH REICHENBACHSTRASSE 27 Munich, DE 80469 |
| Contact | Maximilian Zucker |
| Correspondent | Maximilian Zucker VERUM DIAGNOSTICA GMBH REICHENBACHSTRASSE 27 Munich, DE 80469 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-03 |
| Decision Date | 2012-07-27 |
| Summary: | summary |