The following data is part of a premarket notification filed by Vermillion, Inc. with the FDA for Ova1 Next Generation.
| Device ID | K150588 |
| 510k Number | K150588 |
| Device Name: | OVA1 Next Generation |
| Classification | Ovarian Adnexal Mass Assessment Score Test System |
| Applicant | VERMILLION, INC. 12117 BEE CAVES RD., BLDG III, SUITE 100 Austin, TX 78738 |
| Contact | Benjamin A Kimball |
| Correspondent | Benjamin A Kimball VERMILLION, INC. 12117 BEE CAVES RD., BLDG III, SUITE 100 Austin, TX 78738 |
| Product Code | ONX |
| CFR Regulation Number | 866.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860942000106 | K150588 | 000 |