The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs Acute Care Betahcg And Nt-probnp Testpak And Testpak Assay, Calpak And Dilpak.
| Device ID | K060548 |
| 510k Number | K060548 |
| Device Name: | STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101 |
| Contact | Pamela A Jurga |
| Correspondent | Pamela A Jurga DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101 |
| Product Code | DHA |
| Subsequent Product Code | JIT |
| Subsequent Product Code | NBC |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-01 |
| Decision Date | 2006-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768019722 | K060548 | 000 |
| 00842768004667 | K060548 | 000 |
| 00842768004421 | K060548 | 000 |
| 00842768004414 | K060548 | 000 |
| 00842768004407 | K060548 | 000 |