The following data is part of a premarket notification filed by Diagnostica Stago, Incorporated with the FDA for Sta-r Evolution Expert Series Hemostasis System Automated Multi-parametric Analyzer.
| Device ID | K093001 |
| 510k Number | K093001 |
| Device Name: | STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | DIAGNOSTICA STAGO, INCORPORATED 5 CENTURY DRIVE Parsipppany, NJ 07054 |
| Contact | Umberto V Parrotta |
| Correspondent | Umberto V Parrotta DIAGNOSTICA STAGO, INCORPORATED 5 CENTURY DRIVE Parsipppany, NJ 07054 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2009-12-18 |
| Summary: | summary |