The following data is part of a premarket notification filed by True Diagnostics, Inc with the FDA for Truedx Hcg Early Result Pregnancy Test (midstream Format), Truedx Hcg Early Result Pregnancy Test (cassette Format), Vericlear Early Result Pregnancy Test (midstream Format), Vericlear Early Result Pregnancy Test (cassette Format).
| Device ID | K172257 |
| 510k Number | K172257 |
| Device Name: | TrueDX HCG Early Result Pregnancy Test (Midstream Format), TrueDX HCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | True Diagnostics, Inc 2782 Loker Ave West Carlsbad, CA 92010 |
| Contact | Jerry Lee |
| Correspondent | Jinjie Hu Biologics Consulting Group 1555 King St., Suite 300 Alexandria, VA 22314 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-26 |
| Decision Date | 2017-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917198931 | K172257 | 000 |
| 10311917198924 | K172257 | 000 |
| 10311917198917 | K172257 | 000 |
| 10311917198900 | K172257 | 000 |
| 10311917198894 | K172257 | 000 |
| 10810028774084 | K172257 | 000 |
| 10633472601986 | K172257 | 000 |
| 10633472601948 | K172257 | 000 |
| 10633472601931 | K172257 | 000 |