The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs Acute Care Cardiophase Hscrp Testpak.
| Device ID | K062924 |
| 510k Number | K062924 |
| Device Name: | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK |
| Classification | Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
| Contact | Pamela A Jurga |
| Correspondent | Pamela A Jurga DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
| Product Code | NQD |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2006-12-26 |
| Summary: | summary |