The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs Acute Care Mb Isoenzyme Of Creatine Kinase (ckmb) Test Pak; Stratus Cs Acute Care Ckmb Testpak..
| Device ID | K051650 |
| 510k Number | K051650 |
| Device Name: | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG.500 M.S. 514; PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Pamela A Jurga |
| Correspondent | Pamela A Jurga DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG.500 M.S. 514; PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JHX |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JIT |
| Subsequent Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-21 |
| Decision Date | 2005-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768004629 | K051650 | 000 |
| 00842768004612 | K051650 | 000 |
| 00842768004605 | K051650 | 000 |
| 00842768004544 | K051650 | 000 |
| 00842768004537 | K051650 | 000 |
| 00842768004520 | K051650 | 000 |
| 00842768004513 | K051650 | 000 |
| 00842768004506 | K051650 | 000 |
| 00842768004490 | K051650 | 000 |