The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Dade Tru-liquid Cardiac Control.
| Device ID | K973974 |
| 510k Number | K973974 |
| Device Name: | DADE TRU-LIQUID CARDIAC CONTROL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Contact | Betty Hernandez-labadie |
| Correspondent | Betty Hernandez-labadie DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-20 |
| Decision Date | 1997-11-06 |
| Summary: | summary |