The following data is part of a premarket notification filed by Ameditech, Inc. with the FDA for Ameditech Immutest Hcg Pregancy Test.
| Device ID | K023126 |
| 510k Number | K023126 |
| Device Name: | AMEDITECH IMMUTEST HCG PREGANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | AMEDITECH, INC. 10340 CAMINO SANTA FE SUITES F-G San Diego, CA 92121 |
| Contact | John Wu |
| Correspondent | John Wu AMEDITECH, INC. 10340 CAMINO SANTA FE SUITES F-G San Diego, CA 92121 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-19 |
| Decision Date | 2002-11-18 |