The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Aps/pt Igg And Igm Elisa.
| Device ID | K090755 |
| 510k Number | K090755 |
| Device Name: | QUANTA LITE APS/PT IGG AND IGM ELISA |
| Classification | Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | D. Walter L Binder |
| Correspondent | D. Walter L Binder INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | OPN |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2010-02-01 |