The following data is part of a premarket notification filed by Ai De Diagnostic Co., Ltd. with the FDA for One Step Hcg Pregnancy Test.
| Device ID | K062703 |
| 510k Number | K062703 |
| Device Name: | ONE STEP HCG PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | AI DE DIAGNOSTIC CO., LTD. 1929 WOODBERRY COURT Iowa City, IA 52246 |
| Contact | Lin Wang |
| Correspondent | Lin Wang AI DE DIAGNOSTIC CO., LTD. 1929 WOODBERRY COURT Iowa City, IA 52246 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2007-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50096295133214 | K062703 | 000 |
| 00860002273006 | K062703 | 000 |