The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Pt-multi-calibrator, Model Opat07.
| Device ID | K093848 |
| 510k Number | K093848 |
| Device Name: | PT-MULTI-CALIBRATOR, MODEL OPAT07 |
| Classification | Plasma, Coagulation Control |
| Applicant | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-16 |
| Decision Date | 2010-12-20 |
| Summary: | summary |