The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Stratus Myoglobin Fluorometric Enzyme Immunoassay.
| Device ID | K922125 |
| 510k Number | K922125 |
| Device Name: | STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Nancy A Hornbaker |
| Correspondent | Nancy A Hornbaker BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-06 |
| Decision Date | 1992-07-21 |