The following data is part of a premarket notification filed by Coretests, Inc. with the FDA for One Step Hcg Pregnancy Test.
| Device ID | K150063 |
| 510k Number | K150063 |
| Device Name: | One Step HCG Pregnancy Test |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Coretests, Inc. 6190 Yarrow Drive Carlsbad, CA 92011 |
| Contact | Wen Li |
| Correspondent | Wen Li Coretests, Inc. 6190 Yarrow Drive Carlsbad, CA 92011 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-13 |
| Decision Date | 2015-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850042559014 | K150063 | 000 |
| 10850042559007 | K150063 | 000 |