The following data is part of a premarket notification filed by Diagnostics Stago S.a.s. with the FDA for Pool Norm.
| Device ID | K142132 |
| 510k Number | K142132 |
| Device Name: | POOL NORM |
| Classification | Plasma, Coagulation Control |
| Applicant | Diagnostics Stago S.A.S. 125 AVENUE LOUIS ROCHE Gennevilliers, FR 92230 |
| Contact | Marie Compagnon-riobe |
| Correspondent | Marie Compagnon-riobe Diagnostics Stago S.A.S. 125 AVENUE LOUIS ROCHE Gennevilliers, FR 92230 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2014-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13607450011392 | K142132 | 000 |