STA R MAX
System, Multipurpose For In Vitro Coagulation Studies
DIAGNOSTICA STAGO S.A.S.
The following data is part of a premarket notification filed by Diagnostica Stago S.a.s. with the FDA for Sta R Max.
Pre-market Notification Details
| Device ID | K151867 |
| 510k Number | K151867 |
| Device Name: | STA R MAX |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | DIAGNOSTICA STAGO S.A.S. 125 AVENUE LOUIS ROCHE Gennevilliers, FR 92230 |
| Contact | Arnaud Collin |
| Correspondent | James Monroe DIAGNOSTICA STAGO, INCORPORATED 5 CENTURY DRIVE 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 | 2015-07-09 |
| Decision Date | 2015-08-07 |
| Summary: | summary |
Trademark Results [STA R MAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STA R MAX 79158926 4801739 Live/Registered |
DIAGNOSTICA STAGO 2014-09-24 |
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