The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Stratus(r) Ck-mb Fluorometric Enzyme Immunoassay.
| Device ID | K900806 |
| 510k Number | K900806 |
| Device Name: | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Nancy A Hornbaker |
| Correspondent | Nancy A Hornbaker BAXTER HEALTHCARE CORP. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-21 |
| Decision Date | 1990-03-23 |