The following data is part of a premarket notification filed by Eucardio Laboratory, Inc. with the FDA for Uc Imu B.
| Device ID | K904137 |
| 510k Number | K904137 |
| Device Name: | UC IMU B |
| Classification | Lipoprotein, Low-density, 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 | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1990-11-21 |