The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Dade Stratus Troponin-i Control.
| Device ID | K951888 |
| 510k Number | K951888 |
| Device Name: | DADE STRATUS TROPONIN-I CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | DADE INTL., INC. P.O. BOX 520672 Miami, FL 33152 -0672 |
| Contact | Alina Caraballo |
| Correspondent | Alina Caraballo DADE INTL., INC. P.O. BOX 520672 Miami, FL 33152 -0672 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-07-13 |