The following data is part of a premarket notification filed by Vela Diagnostics Usa Inc. with the FDA for Sentosa Sa201 Hsv 1/2 Qualitative Pcr Test.
| Device ID | K172509 |
| 510k Number | K172509 |
| Device Name: | Sentosa SA201 HSV 1/2 Qualitative PCR Test |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | Vela Diagnostics USA Inc. 353C US Route 46 West Suite 250 Fairfield, NJ 07004 |
| Contact | Donald Henton |
| Correspondent | Donald Henton Vela Diagnostics USA Inc. 353C US Route 46 West Suite 250 Fairfield, NJ 07004 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2018-02-01 |
| Summary: | summary |