The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Sysmex Automated Coagulation Analyzer / Model # Ca-1500.
| Device ID | K011235 |
| 510k Number | K011235 |
| Device Name: | SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | DADE BEHRING, INC. 13251 NW 9TH TERRACE Miami, FL 33182 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE BEHRING, INC. 13251 NW 9TH TERRACE Miami, FL 33182 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-23 |
| Decision Date | 2001-07-20 |