The following data is part of a premarket notification filed by Eucardio Laboratory, Inc. with the FDA for Uc Imu A.
| Device ID | K904125 |
| 510k Number | K904125 |
| Device Name: | UC IMU A |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | EUCARDIO LABORATORY, INC. 9235 TRADE PLACE, STE H San Diego, CA 92126 |
| Contact | Wang |
| Correspondent | Wang EUCARDIO LABORATORY, INC. 9235 TRADE PLACE, STE H San Diego, CA 92126 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1990-09-24 |