The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Sysmex Automated Coagulation Analyzer, Model Ca-500.
| Device ID | K992763 |
| 510k Number | K992763 |
| Device Name: | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 |
| Classification | Instrument, Coagulation, Automated |
| Applicant | DADE BEHRING, INC. 1851 DELAWARE PKWY. Miami, FL 33125 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE BEHRING, INC. 1851 DELAWARE PKWY. Miami, FL 33125 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-17 |
| Decision Date | 1999-09-21 |
| Summary: | summary |