The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Dade Stratus Ck-mb Fluorometric Enzyme Immunoassay.
| Device ID | K972782 |
| 510k Number | K972782 |
| Device Name: | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | DADE INTL., INC. P.O. BOX 6101 Newark, DE 19714 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DADE INTL., INC. P.O. BOX 6101 Newark, DE 19714 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-25 |
| Decision Date | 1997-08-15 |
| Summary: | summary |