The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Sysmex Ca-6000.
| Device ID | K964139 |
| 510k Number | K964139 |
| Device Name: | SYSMEX CA-6000 |
| Classification | Instrument, Coagulation, Automated |
| Applicant | DADE INTL., INC. 9750 N.W. 25TH ST. Miami, FL 33172 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE INTL., INC. 9750 N.W. 25TH ST. Miami, FL 33172 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-02-06 |
| Summary: | summary |