The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Ca-1000 Automated Coagulation Analyzer.
| Device ID | K931149 |
| 510k Number | K931149 |
| Device Name: | CA-1000 AUTOMATED COAGULATION ANALYZER |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 4410 CERRITOS AVE. Los Alamitos, CA 90720 |
| Contact | Jeme Wallace |
| Correspondent | Jeme Wallace TOA MEDICAL ELECTRONICS USA, INC. 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 | 1993-03-08 |
| Decision Date | 1993-11-03 |