The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash ¿2gp1-domain1; Controls, Hemosil Acustar Anti-¿2gpi Domain1; Controls..
| Device ID | K141274 |
| 510k Number | K141274 |
| Device Name: | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Roger Albesa |
| Correspondent | Roger Albesa INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-16 |
| Decision Date | 2015-02-13 |
| Summary: | summary |