The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus (r) Cs Stat Fluorometric Analyzer, Stratus (r) Cs Ckmb Test Pak.
| Device ID | K984067 |
| 510k Number | K984067 |
| Device Name: | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-16 |
| Decision Date | 1999-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768024863 | K984067 | 000 |
| 00842768004681 | K984067 | 000 |
| 00842768004674 | K984067 | 000 |
| 00842768004599 | K984067 | 000 |
| 00842768004551 | K984067 | 000 |
| 00842768004476 | K984067 | 000 |
| 00842768004469 | K984067 | 000 |
| 00842768004445 | K984067 | 000 |
| 00842768004438 | K984067 | 000 |