The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Toa Medical Electronics Ca-5000.
| Device ID | K942097 |
| 510k Number | K942097 |
| Device Name: | TOA MEDICAL ELECTRONICS CA-5000 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | SYSMEX CORP. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Contact | Jeme Wallace |
| Correspondent | Jeme Wallace SYSMEX CORP. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-14 |
| Decision Date | 1995-03-24 |