The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dade Behring Heparin Calibrator And Controls.
| Device ID | K042941 |
| 510k Number | K042941 |
| Device Name: | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS |
| Classification | Plasma, Control, Normal |
| Applicant | DADE BEHRING, INC. GLASCO B500 M.S. 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE BEHRING, INC. GLASCO B500 M.S. 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-25 |
| Decision Date | 2004-12-02 |
| Summary: | summary |