The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta-r Evolution Automated Multi-parametric Analyzer.
| Device ID | K082675 |
| 510k Number | K082675 |
| Device Name: | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Umberto V Parrotta |
| Correspondent | Umberto V Parrotta DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, 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 | 2008-09-15 |
| Decision Date | 2008-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450590272 | K082675 | 000 |
| 03607450590265 | K082675 | 000 |
| 03607450590135 | K082675 | 000 |
| 03607450590104 | K082675 | 000 |
| 03607450589795 | K082675 | 000 |
| 03607450589788 | K082675 | 000 |