The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Toa Medical Electronics Ca-1000.
Device ID | K942096 |
510k Number | K942096 |
Device Name: | TOA MEDICAL ELECTRONICS CA-1000 |
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 |