The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Cardiac Troponin-i (trop) Calibrator.
| Device ID | K973668 |
| 510k Number | K973668 |
| Device Name: | CARDIAC TROPONIN-I (TROP) CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE INTL., INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE INTL., INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-25 |
| Decision Date | 1997-10-20 |
| Summary: | summary |