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 |