The following data is part of a premarket notification filed by Eucardio Laboratory, Inc. with the FDA for Uc Qik 1-step Hcg Test.
| Device ID | K942464 |
| 510k Number | K942464 |
| Device Name: | UC QIK 1-STEP HCG TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | EUCARDIO LABORATORY, INC. 9235 TRADE PLACE, STE H San Diego, CA 92126 |
| Contact | Richard Wang |
| Correspondent | Richard Wang EUCARDIO LABORATORY, INC. 9235 TRADE PLACE, STE H San Diego, CA 92126 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-24 |
| Decision Date | 1994-09-20 |