The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Stratus Ck-mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-mb Dendrimer High Sample Diluent.
| Device ID | K952250 |
| 510k Number | K952250 |
| Device Name: | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | DADE INTL., INC. P.O. BOX 520672 Miami, FL 33152 -0672 |
| Contact | Joann H Smith |
| Correspondent | Joann H Smith DADE INTL., INC. P.O. BOX 520672 Miami, FL 33152 -0672 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-15 |
| Decision Date | 1995-07-17 |