The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs Stat Fluorometric Analyzer And Stratus Cs Ckmb Testpak.
| Device ID | K981099 |
| 510k Number | K981099 |
| Device Name: | STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | DADE BEHRING, INC. PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DADE BEHRING, INC. PO 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 | 1998-03-26 |
| Decision Date | 1998-05-26 |
| Summary: | summary |