The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Stratus Myoglobin Gluorometric Enzyme Immunoassay.
| Device ID | K965213 |
| 510k Number | K965213 |
| Device Name: | STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Contact | Radha Goolabsingh |
| Correspondent | Radha Goolabsingh DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-30 |
| Decision Date | 1997-02-10 |
| Summary: | summary |